Jobs in West Chester, OH

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Manager, Maintenance - IDAP is responsible for the overall maintenance program, including preventive, predictive, and corrective maintenance, for the PET/Facility. The role leads a team of skilled technicians, assesses equipment performance, and develops solutions to minimize downtime and improve reliability. It requires extensive collaboration with Operations Area Leaders, Engineering, and OEM suppliers. Job Responsibilities Operations: Own asset reliability and availability, including preventive maintenance (PM) content, effectiveness, and performance. Schedule maintenance activities and ensure mechanical and electronic technical support and troubleshooting coverage for all PET activities across all shifts. Drive continuous improvement and OEE initiatives. Participate in risk analysis of spare parts inventory. Resolve complex maintenance challenges spanning multiple areas, partnering with Senior Managers, Area Managers, and Engineering, and escalating as needed. Documentation & Compliance: Initiate deviations for machine failures, drive root cause analysis, and lead technical investigations and impact assessments, including CAPA implementation. Ensure work is completed in accordance with site SOPs, cGMPs, and EHS procedures. Ensure maintenance documentation and asset management systems are accurate and up to date. Author and review documents including SOPs, equipment specifications, validation test scripts, job aids, and work instructions. Serve as key contact and process owner for regulatory inspections. Leadership & Training: Serve as a maintenance subject-matter expert on engineering projects spanning electronics, controls, and automation, and act as first-line support for project-related work. Provide technical guidance, career development, and performance management to technical team members. Identify technical training requirements across Operations, Engineering, Maintenance, and Controls for new and existing processes and equipment. Maintain external technical relationships with equipment and material suppliers. Education & Experience Minimum Qualifications: Prior experience in a regulated production environment with direct responsibility for equipment maintenance, reliability, and performance. Supervisory experience, including the ability to provide direction to a team of technical resources. Strong communication, leadership, problem-solving, and project management skills. Expertiseinone or moreof the followingdisciplines: equipment, process/materials, maintenance, project delivery, automation/controls, and validation. Ability to challenge and adapt approaches and ways of working. Proven ability to work with all levels within and outside the organization. Preferred Qualifications: Associate degree in Engineering, a related discipline, or equivalent trade school. 5+ years of maintenance experience in a regulated manufacturing environment, including team leadership or supervisory responsibility. Previous experience with automated equipment. The items described here are representative of those that must be met successfully to perform the essential functions of this job. Work Schedule Monday- Friday; Dayshift The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. Sponsorship or support for work authorization,

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com General Duties Read SOPs (Standard Operating Procedures) and excerpts from technical documentation. Author SOPs and Work Instructions in the department's area of responsibility. Train others on systems, software, equipment, machines, procedures, and/or processes. Facilitate team meetings to discuss progress, initiatives, and/or other matters. Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities. Provide leadership, development, and mentoring for others. Evaluate new software and/or tools. Lead and support change control activities. Serve as SME (subject matter expert) for CMMS. Lead coordination of shutdown activities for the plant across all PETs and BETs. Asset Reliability & Performance Develop and execute equipment reliability strategies for packaging and inspection assets. Monitor and analyze equipment performance (OEE, MTBF, MTTR) to identify improvement opportunities. Lead reliability/spare parts meetings. Lead reliability/spare parts meetings. Maintenance Strategy & Optimization Execute and manage master data requests to support BOM accuracy, maintenance plans, and asset reliability. Develop and optimize preventive and predictive maintenance plans. Perform PM effectiveness reviews and adjust frequencies based on failure data. Root Cause Analysis (RCA) & Continuous Improvement Lead and facilitate root cause investigations for major equipment failures. Apply structured RCA methodologies (5-Why, Fishbone, Fault Tree, etc.). Track corrective and preventive actions to closure. Identify recurring failure modes and implement permanent fixes. Identify recurring failure modes and implement permanent fixes. Spare Parts & Asset Lifecycle Management Define and maintain critical spare parts strategies (min/max, stocking levels). Create and maintain spare parts in SAP, including material master data and related attributes. Support BOM accuracy and completeness for production equipment. Evaluate spare part consumption trends and lead time risks. Support Part Equivalency Forms (PEFs) and technical evaluations. Data Analytics & Reliability Reporting Develop and maintain reliability dashboards and KPIs. Analyze work order history to identify trends and bad actors. Analyze work order history to identify trends and bad actors. Capital Projects & Equipment Readiness Provide reliability input during equipment design, FAT/SAT, and commissioning. Ensure maintainability and spare parts strategies are defined for new assets. Support equipment lifecycle planning. Cross-Functional Collaboration Partner with Maintenance, Operations, Engineering, and Quality. Work with OEMs and vendors to resolve chronic equipment issues. Work with OEMs and vendors to resolve chronic equipment issues. Compliance & Documentation Ensure maintenance and reliability practices meet GMP requirements. Support audit readiness for equipment and maintenance programs. Support SOP and job plan development and updates. Ensure data accuracy within SAP and reliability systems. Track preventive maintenance compliance for the site. Minimum Requirements * Significant experience supporting reliability in a manufacturing environment. * Solid experience in Production, Maintenance, leading projects, and/or Engineering Improvements. * Strong mechanical/technical aptitude Preferred Background * Bachelor's degree in engineering, or related science * In-depth knowledge of CMMS. * Significant experience supporting reliability in a regulated or cGMP environment. * CRE (Certified Reliability Engineer), CRL (Certified Reliabi

Relocation Assistance Offered A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The MSAT Process Engineer IV has responsibility for execution of technical aspects of product and/or process technology transfer to the site through successful completion of PPQ. This includes feasibility evaluations, design, execution, and documentation of engineering studies, component specification and evaluation, and all other activities required to support delivery of a complete, validated process to manufacturing. Individuals in this role work closely with Validation, PMO, Supply Chain, Operations, Quality, and technical experts performing transfers to the site to ensure process implementation to commercial manufacturing follows project timelines and corporate standards. This posting is for a Visual Inspection Technical Lead (Automated and Manual) Key Responsibilities Visual Inspection Own all MSAT responsibilities related to visual inspection of filled container closures (automated and manual) Define and maintain visual inspection centerlines, critical process parameters, material fit-for-use criteria, and operating procedures to ensure process capability Serve as site SME for visual inspection equipment and processes Lead continuous improvement efforts including changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated inspection equipment Technology Transfer & Validation Define success criteria for technology transfer and process validation; ensure processes are capable prior to handoff to Manufacturing Generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports Perform and maintain risk management activities for new and existing processes and equipment Lead process validation activities required as a result of changes to validated manufacturing processes Participate in annual product reviews and biennial critical systems reviews Change Control & Investigations Initiate deviations and lead or facilitate technical investigations and impact assessments Identify, develop, and manage change controls to improve processes and address root causes Author, review, and approve SOPs, batch records, rework procedures, validation documents, and change requests Asset & Project Management Coordinate equipment data, capabilities, utilization, efficiencies, and lifecycle management Own user requirements for new asset procurement Develop project justifications and engineering proposals, including input to the capital planning process Maintain external technical relationships with equipment and material suppliers Operations Support Identify technical training needs for Operations, Engineering, and Maintenance Provide on-call support as required Serve as key technical contact during regulatory inspections Minimum Qualifications Significant experience supporting manufacturing operations in a regulated or cGMP environment Demonstrated experience in visual inspection processes, automated vision systems, and process validation or technology transfer in pharmaceuticals or a comparable GMP environment Experience identifying, justifying, implementing, and testing process improvements in a cGMP environment Established track record as a technical SME in visual or process engineering Preferred Qualifications Bachelor's degree in Engineering or a related technical discipline Experience with both automated and manual visual inspection Project management experience, including leading equipment installation and qualification efforts Six Sigma or analytical troubleshooting skills Experience in a LEAN manufacturing environment Profic

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Job Summary The Analyst II, QC Aseptic Control, Leadautonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. This includes operating equipment in various classified/non-classified areas up to a Grade A aseptic environment and in a laboratory setting and maintaining gowning qualification. In addition, the incumbent will perform tasks related to scheduling work and loads, reviewing sampling and lab data, performing project work, leading laboratory investigations, and training and coaching colleagues. Job Responsibilities Schedule work and load the correct pulls in Environmental Monitoring System Troubleshoot methods and processes Develop methods and processes May serve as the primary link between QC team and Operations for day-to-day activities, such as schedules and workload planning Coordinate workflow in Environmental Monitoring team Verify QC data while monitoring for trends and abnormalities Maintain training to perform all Environmental Monitoring technician responsibilities (including maintaining aseptic qualification) when needed Review completed production documentation (for example: logbooks) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance Assign work tasks and activities to others Perform logbook reviews Train others on systems, software, equipment, machines, procedures, and/or processes Answer compliance and process questions from others Communicate policies and procedures to employees Fill in for immediate supervisor when needed Gather, organize, and communicate operational information to others Lead and coordinate investigations and studies with little supervision Lead process improvement activities and teams to meet strategic goals Communicate priorities and progress to team on a continuing basis Ensure that employees have the tools needed to perform their jobs Monitor training of employees to ensure compliance Perform other duties that support Environmental Monitoring, Operations, or Laboratory Processes Hours (Night Shift): 6pm - 6:30am 2/2/3 Schedule (12-Hour Rotating) Minimum Requirements Prior experience in a pharmaceutical production or quality control environment Ability to effectively understand, read, write, communicate and follow instructions in the English language Thorough attention to detail because individual must be capable of keeping accurate records and performing mathematical calculation Preferred Background Bachelor's degree in scientific discipline Prior experience in a sterile or cGxP environment The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary The Analyst II, QC Microbiology role supports the Microbiology Department by performing quality-related tasks for pharmaceutical products to include documenting and conducting testing on a variety of samples, such as raw materials, in-process and finished products, stability samples, water, gas, and environmental samples. Job Responsibilities Read SOPs (Standard Operating Procedures) and excerpts from technical documentation. Write, review, and revise SOPs (Standard Operating Procedures) and/or work instructions for cGMP (Good Manufacturing Practices) manufacturing of commercial product. Complete required training and may train others. Conduct troubleshooting activities. Gather, organize, and communicate operational information to others. Facilitate team meetings to discuss progress, initiatives, and/or other matters. Actively participates in investigations involving manufacturing process areas, related to QC processes or data, such as sampling, deviations potentially affecting QC results, investigational sampling, and testing. Assist with coordinating activities of support groups. Identifies trends in data in order to provide accurate descriptions, identify root causes, and/or identify solutions or improvements. Demonstrates proficiency on authoring Quality records (Deviations, CAPAs, and Change Controls). Identify temporary and permanent fixes to address issues. Alert supervisor or manager when problems occur outside of SOPs (Standard Operating Procedures). Collect, record, and report metrics. Monitor equipment and/or systems for performance and problem indicators. Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities. Consult cross-functionally as an SME (Subject Matter Expert) on systems and/or processes within a functional area. Perform logbook reviews. Lead or participate in process improvement activities and teams to meet strategic goals. Use MAXIMO and/or CMMS (Computerized Maintenance Management System) to manage logistics. Interact with regulatory agency individuals during audits and inspections, when necessary. Author, review, and revise documentation needed for cGMP (Good Manufacturing Practices) manufacturing of commercial product. Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments. Coordinate qualification activities. Perform routine sampling activities on the facility utilities. Recommend compliance resolutions to management. Minimum Qualifications Working knowledge of cGXP requirements and a strong familiarity with production operations. Good problem solving skills. Preferred Qualifications Bachelor's degree in biology, microbiology, or related discipline. At least 2 year of laboratory experience in pharmaceutical industry. Prior experience supporting microbiological testing in a sterile pharmaceutical operation environment. This position may also include the following conditions: This role is primarily non-sedentary. May include but not limited to standing, walking, repetitive motion, and chemical usage. All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role. The items described here are representative of those that must be met successfully to perform the essential functions of this job. Sponsorship or support for work authorization, including visas, is not

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com This position will require working in various Controlled/Non-Classified areas. The Packaging Technicianperforms a variety of manufacturing tasks (operates equipment, performs in-process monitoring, lineclearances, cosmetic inspection, cleaning and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) to achieve aprescribed level of purity, quality, and consistency in product and work output in accordance with cGMPs. **Night shift position working 6pm- 6:30am. 2 days on, 2 days off, 3 days on, 3 days off then the rotation starts over again. Job Responsibilities * Perform the duties of operating assigned machinery consisting of servicing machines withmaterials, monitoring equipment status, reintroduction of materials, manually palletizing finishedmaterials, and assuring a smooth flow of product. * Be able to start-up machinery including equipment set-up, perform recipe selection and data entry on manufacturing computerized system (SCADA and HMI), make minor adjustments, andperform critical sensor challenges. * Perform manual packaging tasks as required including hand packaging and rework of in-processand finished material. * Operate light material handling equipment (motorized and manual pallet jacks, non-motorizedlifts) as the need arises to safely move, store or deliver material to the proper location. * Perform visual quality inspection and sampling of in-process materials. Promptly escalateconcerns to Lead and Process Facilitator as needed. * Perform minor troubleshooting including clearing minor jams and identifying equipment defects. * Work collaboratively with technical resources to resolve equipment issues as needed. * Perform inventory control and reconciliation activities, which may require the use of SAP andWES in a limited role. * Perform cleaning, housekeeping and line clearance activities for assigned areas to maintain acGMP environment. This includes assembling, disassembling, and sanitizing various packagingequipment. * Perform batch record and GMP documentation entries. Perform mathematical computation asneeded. * Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO,human safety, material handling, chemical handling, and spill controls. Report all discrepancies to process facilitator. * Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs andestablished safety and quality procedures. * Support lean activities and process improvement work such as performing 5S in the work area,participating in problem-solving, and manual tracking of performance data for OEE and processimprovement analysis. * Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train andconduct evaluations on other team members for training qualifications. * Review process documents such as operational SOPs, forms, and batch records for accuracy. * Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise. * Execute protocols as required as a part of equipment qualification and process validation work. * Be flexible and support other work areas within the Manufacturing Team as needed. * Perform all other assigned duties with minimal supervision under the direction of the processfacilitator or designee as needed. * Acquire and maintain all required certifications and qualifications for the assigned work area. * Capable and motivated to learn new skills and develop new capabili

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com This position will require working in various Controlled/Non-Classified areas. The Packaging Technicianperforms a variety of manufacturing tasks (operates equipment, performs in-process monitoring, lineclearances, cosmetic inspection, cleaning and completes batch record entries) and supports improvement activities (5S, participate in problem-solving and Kaizen events, manual data collection) to achieve aprescribed level of purity, quality, and consistency in product and work output in accordance with cGMPs. Job Responsibilities * Perform the duties of operating assigned machinery consisting of servicing machines withmaterials, monitoring equipment status, reintroduction of materials, manually palletizing finishedmaterials, and assuring a smooth flow of product. * Be able to start-up machinery including equipment set-up, perform recipe selection and data entry on manufacturing computerized system (SCADA and HMI), make minor adjustments, andperform critical sensor challenges. * Perform manual packaging tasks as required including hand packaging and rework of in-processand finished material. * Operate light material handling equipment (motorized and manual pallet jacks, non-motorizedlifts) as the need arises to safely move, store or deliver material to the proper location. * Perform visual quality inspection and sampling of in-process materials. Promptly escalateconcerns to Lead and Process Facilitator as needed. * Perform minor troubleshooting including clearing minor jams and identifying equipment defects. * Work collaboratively with technical resources to resolve equipment issues as needed. * Perform inventory control and reconciliation activities, which may require the use of SAP andWES in a limited role. * Perform cleaning, housekeeping and line clearance activities for assigned areas to maintain acGMP environment. This includes assembling, disassembling, and sanitizing various packagingequipment. * Perform batch record and GMP documentation entries. Perform mathematical computation asneeded. * Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO,human safety, material handling, chemical handling, and spill controls. Report all discrepancies to process facilitator. * Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs andestablished safety and quality procedures. * Support lean activities and process improvement work such as performing 5S in the work area,participating in problem-solving, and manual tracking of performance data for OEE and processimprovement analysis. * Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train andconduct evaluations on other team members for training qualifications. * Review process documents such as operational SOPs, forms, and batch records for accuracy. * Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise. * Execute protocols as required as a part of equipment qualification and process validation work. * Be flexible and support other work areas within the Manufacturing Team as needed. * Perform all other assigned duties with minimal supervision under the direction of the processfacilitator or designee as needed. * Acquire and maintain all required certifications and qualifications for the assigned work area. * Capable and motivated to learn new skills and develop new capabilities on an on-going basis tocontribute to the success of the Process Execution Team. * Ability to work effectively in a team e

Relocation Assistance Offered A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary The Automation Engineer III is responsible for delivering technical projects for the manufacturingintelligence and automation systems. The engineer will provide change management and lifecycle analysis for systems within their area of expertise. Responsibilities Interface with several types of equipment and systems, including but not limited to PLCs, SCADAs, HMIs, Servers, Databases, Data Historian, Visualization, and other automation equipment. Experience with networking, including but not limited to VLAN, Subnets, and IP protocols. Participate and support in the design, optimization, commissioning, or validation of newly procured or existing equipment as the automation lead. Consult cross-functionally and assist system owners in process development as the automation subject matter expert. Review and approve requirements, specifications, drawings, coding procedures, and guideline. Provide technical guidance and train others on systems, software, equipment, machines, procedures, and/or processes. Communicate priorities and progress to the team on a continuing basis. High technical ability with a troubleshooting approach. Identify temporary and permanent fixes to address issues. Review and approve documentation needed for the qualification of equipment and processes. Author, review, and revise SOPs and specifications to maintain equipment, systems, and/or facilities. Ensure proper documentation practices during maintenance processes. Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance. Assess and implement improvements in productivity, waste generation, quality, and cost. Lead and coordinate investigations and studies with little supervision. Interact with regulatory agency personnel during audits and inspections. Perform quality audits to ensure devices used are in proper working condition. Provide 24/7 support to others as part of a rotating on-call support system. All other tasks as needed or assigned by the supervisor. Minimum Qualifications Significant experience supporting manufacturing operations in a regulated or cGMP environment Experience with the following Automation systems (PLC, HMI, SCADA), including but not limited to Rockwell, Inductive (Ignition), Aveva (Wonderware), Siemens, Emerson (GE), or B&R Preferred Qualifications Bachelor's degree in Engineering, computer science or a related discipline Knowledge of GMP principles, GAMP 5 and ISA standards Experience with FactoryTalk Batch, Data Historian systems, and Microsoft SQL database designs This position may also include the following conditions: Sitting and working on computers, meeting with stakeholders for design requirements, working with vendors and regulatory authorities, occasionally working on the plant floor and interacting with equipment. The items described here are representative of those that must be met successfully to perform the essential functions of this job. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Maintenance Technician III is responsible for performing ongoing corrective, predictive and preventative maintenance for the process equipment within the assigned operating area. This position also could entail the execution of setup and changeover support for all process equipment used in various classified areas up to a Class 100 aseptic environment. This role requires the ability to perform mechanical and electrical troubleshooting to ensure optimal operation of the process equipment. The Maintenance Technician III will also perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects. The Maintenance Technician III reports to a Supervisor, Maintenance. Job Responsibilities Complete emergency repair, rebuilding, changeover and inspection work on process related equipment. Install, inspect, test, adjust, repair and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner. Troubleshoot the following Automation systems; PLCs, HMIs, SCADA. Ability to interpret diagrams, drawing, PLC code and other schematics. Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs. Responsible for equipment and system performance through data monitoring within the assigned operating area. Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment. Provide training to operators for equipment set-up and for minor adjustments or repairs. Install new equipment and oversee equipment upgrades according to site SOPs. Perform 5S activities and maintain organization of operating areas. Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with "Material Safety Data Sheets" for area chemicals. Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed. Work with minimal supervision under the direction of the Maintenance Facilitator, Process Facilitator, Engineer, or other activity leads. Perform roles of Technician and Mechanical Technician as required to support daily PET activities. Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs. Follow and maintain compliance with established MRO procedures and inventory control. Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas. (Area Dependent) Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Perform other similar and related responsibilities as assigned by area management. Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the manufacturing. Minimum Requirements: Experience in a regulated production environment, specifically responsible for equipment maintenance and performance Experience with some of following Automation systems; PLCs, HMIs, SCADA, Rockwell Inductive (Ignition) Aveva (Wond

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com This position is responsible for performing ongoing corrective, predictive, and preventative maintenance for the process equipment within the assigned operating area. This position also could entail the execution of setup and changeover support for all process equipment used in various classified areas up to a Class 100 aseptic environment. In addition, the role requires the ability to perform mechanical and electrical troubleshooting in order to ensure optimal operation of the process equipment. The individual will also perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects. * Complete emergency repair, rebuilding, changeover, and inspection work on process related equipment. Install, inspect, test, adjust, repair, and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner * Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs * Responsible for equipment and system performance through data monitoring within the assigned operating area * Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment * Provide training to operators for equipment set-up and for minor adjustments or repairs * Install new equipment and oversee equipment upgrades according to site SOPs * Perform 5S activities and maintain organization of operating areas * Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs, and established safety procedures in accordance with OSHA requirements and guidelines * Be familiar with "Material Safety Data Sheets" for area chemicals * Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed * Work with minimal supervision under the direction of the Maintenance Manager, Process Managers, Engineer, or other activity leads * Perform roles of Technician and Mechanical Technician as required to support daily PET activities * Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs * Follow and maintain compliance with established MRO procedures and inventory control * Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities * Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas (Area Dependent) * Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment * Perform other similar and related responsibilities as assigned by area management * Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the PET Minimum Qualifications Prior experience in a regulated production environment, specifically responsible for equipment maintenance and performance Prior people leadership experience, including supervising, mentoring, or developing direct reports Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and r

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Job Description Position Summary The Supervisor, Quality Aseptic Control (Night Shift) is responsible for execution of the environmental monitoring and aseptic control activities in accordance with the site operating strategy and the aseptic strategy. This includes leading a high performing team of leads and technicians working a 24/7 shift pattern; therefore, they must be willing to work a flexible schedule that allows oversight of all production shifts.As a responsible leader for the operation, the role includes maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as EHS obligations and Resilience standards. As a member of QC leadership, the individual will also be responsible for delivering QC and site Quality priorities and initiatives, as appropriate. Job Responsibilities Develop and maintain a high performing team of Aseptic Control Team Leads and Technicians Trained and able to perform all EM technician responsibilities (including maintaining aseptic qualification) when needed Accountable for the completion of: Monthly and annual trending EMPQ and related document updates Deviations and investigations related to environmental monitoring process or results Review completed production and laboratory documentation (i.e., log books) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance Train others on procedures and/or processes Answer compliance and process questions from others, including regulatory agencies Communicate policies and procedures to employees Gather, organize, and communicate operational information to others Lead process improvement activities and teams to meet strategic goals Communicate priorities and progress to team on a continuing basis Ensure that employees have the tools needed to perform their jobs safely Monitor training of employees to ensure compliance Other duties that support Environmental Monitoring, Operations, or Laboratory processes may be assigned. This is a night shift position 6 PM-6:30 AM 2 days on, 2 days off, 3 days on, 3 days off and the rotation starts over Minimum Qualifications Strong communication and leadership skills Problem solving skills Training or experience in environmental monitoring, microbiology, quality control, validation, technology transfer, or change control Knowledge or previous experience in managing technical programs/projects Strong mechanical, troubleshooting, and problem-solving abilities Ability to direct and participate in cross-functional teams Project management skills Experience in production or quality control environment Preferred Qualifications Bachelor's degree in engineering, pharmacy, or a related science or business Experience working in a LEAN manufacturing environment Working knowledge of LDMS or Veeva, Microsoft applications, SAP Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Maintenance Technician III is responsible for performing ongoing corrective, predictive and preventative maintenance for the process equipment within the assigned operating area. This position also could entail the execution of setup and changeover support for all process equipment used in various classified areas up to a Class 100 aseptic environment. This role requires the ability to perform mechanical and electrical troubleshooting to ensure optimal operation of the process equipment. The Maintenance Technician III will also perform basic mechanical training to Production Operators and serve as a resource to help implement continuous improvement projects. The Maintenance Technician III reports to a Supervisor, Maintenance. Job Responsibilities Complete emergency repair, rebuilding, changeover and inspection work on process related equipment. Install, inspect, test, adjust, repair and perform line turnarounds, changeovers, and preventative maintenance per established procedures in a timely and efficient manner. Troubleshoot the following Automation systems; PLCs, HMIs, SCADA. Ability to interpret diagrams, drawing, PLC code and other schematics. Complete documentation and required functions in the work order system to close out activities in compliance with cGMPs. Responsible for equipment and system performance through data monitoring within the assigned operating area. Use a variety of testing, tools, and measuring equipment in the efficient maintenance and troubleshooting of electronic, environmental monitoring, pneumatic, hydraulic, and mechanical line equipment. Provide training to operators for equipment set-up and for minor adjustments or repairs. Install new equipment and oversee equipment upgrades according to site SOPs. Perform 5S activities and maintain organization of operating areas. Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with "Material Safety Data Sheets" for area chemicals. Perform batch record and GMP documentation entries. Maintain records and/or logs as required in performance of job responsibilities. This will include mathematical computation where needed. Work with minimal supervision under the direction of the Maintenance Facilitator, Process Facilitator, Engineer, or other activity leads. Perform roles of Technician and Mechanical Technician as required to support daily PET activities. Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs. Follow and maintain compliance with established MRO procedures and inventory control. Serve as a project resource to PET to assist in the follow up and timely implementation of projects and validation activities Responsible for maintaining Aseptic Processing and Gowning certifications as required to support assigned work areas. (Area Dependent) Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Perform other similar and related responsibilities as assigned by area management. Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the manufacturing. Minimum Requirements: Experience in a regulated production environment, specifically responsible for equipment maintenance and performance Experience with some of following Automation systems; PLCs, HMIs, SCADA, Rockwell Inductive (Ignition) Aveva (Wond

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary The Automation Engineer II is an engineer responsible for enhancing programs across a broad spectrum of functions at the West Chester Site. In this role, you will lead and advise on projects spanning various departments within the site, including Formulation, Aseptic Filling, Automated Inspection, Device Assembly, Packaging, Building Automated System, AMHS, and a site-level Historian system. Collaboration with cross-functional teams, such as MS&T, Engineering, Digital, Quality, Validation, and other key stakeholders, is integral to defining requirements, project execution, and the sustained operation of multiple automated systems on-site. This position is an excellent fit for Automation Engineers who possess problem-solving abilities and a service-oriented mindset. It provides an opportunity for professionals to expand their technical expertise while gaining exposure to a diverse array of systems and actively contributing to their growth and optimization. Responsibilities Participate and support in the design, optimization, commissioning, or validation of newly procured or existing equipment as the automation lead. Interface with several types of equipment and systems, including but not limited to PLCs, SCADAs, HMIs, Servers, Databases, Data Historian, Visualization, and other automation equipment. Consult cross-functionally and assist system owners in process development as the automation subject matter expert. Review and approve requirements, specifications, drawings, coding procedures, and guidelines. Provide technical guidance and train others on systems, software, equipment, machines, procedures, and/or processes. High technical ability with a troubleshooting approach Identify temporary and permanent fixes to address issues. Review and approve documentation needed for the qualification of equipment and processes. Author, review, and revise SOPs and specifications to maintain equipment, systems, and/or facilities. Comply with all SOPs. Ensure proper documentation practices during maintenance processes. Recommend and initiate activities to ensure area and equipment are maintained in a state of compliance. Assess and implement improvements in productivity, waste generation, quality, and cost. Lead and coordinate investigations and studies with little supervision. Interact with regulatory agency personnel during audits and inspections. Perform quality audits to ensure devices used are in proper working condition. Provide 24/7 support to others as part of a rotating on-call support system. All other tasks as needed or assigned by the supervisor. Minimum Qualifications Experience supporting manufacturing operations in a regulated or cGMP environment Experience with some of the following Automation systems (PLC, HMI, SCADA): Rockwell, Inductive (Ignition), Aveva (Wonderware), Siemens, Emerson (GE), or B&R Ability to work independently with excellent attention to detail and a desire to learn about manufacturing technologies Preferred Qualifications Bachelor's degree in Engineering, Computer Science, or a related discipline Experience with FactoryTalk Batch Experience with Data Historian and Visualization systems such as Aveva PI (OSI PI) Experience with Microsoft SQL database design Knowledge of GAMP 5 and ISA standards Knowledge of change control, deviation, CAPA, validation, and qualification principles Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Manufacturing Technician II reports to a Process Execution Team (PET)/ MSAT Supervisor/Manager on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified and Classified areas. The Filling Technician operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs. **This position will start on a dayshift Monday-Friday 8 hour schedule. It will support the new cartridge filling line tech transfer within the MSAT team and then eventually transition to commercial operations team at the commercial handover. At the commercial handover, the position will move to a 2-2-3 12 hour shift schedule, remaining on dayshift. Position Summary & Responsibilities * Perform the duties of operating assigned machinery consisting of servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product. * Responsible for assembling, disassembling, operating and sanitizing various Filling equipment. * Perform and execute filter integrity testing as needed per SOP. * Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. * Be able to start up and make minor adjustments to machinery. * Computer on-line may require some data input. This includes SCADA and HMI entries. * Perform visual and physical checks of in-process and finished materials as requested. * Work with various printing devices including printing mats. * Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed. * Knowledge of product security controls and material handling equipment. * Responsible for outgoing quality level. * Understand aseptic behaviours, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment. * Perform inventory control and reconciliation activities, which may require the use of SAP in a limited role. * Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines * Be familiar with "Material Safety Data Sheets" for area chemicals. * Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator. * Assist mechanical staff with preventive maintenance procedures, as required. * Support lean activities and process improvement work such as performing 5S in the work area and Single Minute Exchange of Die (SMED), participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis. * Assist with executing Validation/Engineering protocols for processes/equipment. * Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise. * Be flexible in training and support other Filling functions as needed. * Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed. * Acquire and maintain all required certification and qualifications for the assigned work area. * Capable and motivated to learn new skills and develop new capabiliti

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Summary The Quality Control Systems Engineer will work closely with Quality Control (QC), Digital, and Quality/CSV to ensure the reliable, compliant operation of critical laboratory applications and data acquisition systems. This role will act as a senior technical contributor and delivery lead for LabVantage LIMS/LES, with additional responsibility supporting systems such as Empower, Moda, and Novatek. The Engineer will lead projects to enhance system functionality, enable new business capabilities, and maintain audit readiness in LabVantage and will own development activities from custom design and build to testing. The position requires deep LabVantage expertise, cross-functional leadership, and the ability to design compliant solutions in a GxP-regulated environment in partnership with Quality. Position Summary & Responsibilities Serve as senior LabVantage technical subject matter expert for project execution and system enhancements, responsible for configuration, deployment, validation, adoption, and troubleshooting of LabVantage modules. Lead and manage enhancement projects to expand or upgrade QC applications, including rollouts of new LabVantage modules and development of reports and labels. Partner with scientific business stakeholders (e.g., QC) to gather and document user requirements and create actionable application designs and implementation plans. Provide troubleshooting and guidance for LabVantage issues and complex configurations. Support system integrations and assist in architecting solutions to enable secure and reliable data flow across applications. Serve as system support for QC applications, managing user accounts, access rights, roles, and privileges. Ensure reliable, compliant operation of critical QC systems. Manage change controls, deviations, and related records in the electronic Quality Management System (eQMS) for QC system projects. Partner with Quality and CSV to ensure regulatory compliance. Own and execute GxP validation activities for projects and system enhancements. Develop and maintain validation and system lifecycle documentation (e.g., SRS, specifications, IQ/OQ/PQ testing, SOPs). Maintain compliance and audit readiness of assigned systems, ensuring adherence to 21 CFR Part 11 and other regulatory standards. Minimum Qualifications Experience developing and maintaining LabVantage reports preferably using Jaspersoft Studio. Extensive experience maintaining LabVantage LIMS in biotech, pharma, or life sciences. Experience developing and maintaining label printing solutions, preferably in BarTender. Strong project leadership experience, including planning and managing multiple concurrent projects. Excellent communication skills, with the ability to translate technical concepts for non-technical stakeholders. Strong analytical and problem-solving skills, with the ability to independently diagnose and resolve complex system issues. Programming experience using SQL. Experience with LabVantage architecture, including JBOSS, Microsoft SQL Server, and/or Apache or other applicable program. Experience with GxP validation and understanding of regulatory requirements (e.g., GxP, 21 CFR Part 11). Proven experience authoring and maintaining SOPs, validation protocols, and system lifecycle documents. Preferred Qualifications Bachelor's degree in a scientific, technical, or related discipline. 5+ years of experience maintaining LabVantage LIMS in biotech, pharma, or life sciences. Experience with system lifecycle management, including upgrades, patches, and periodic reviews. Experience w

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Brief Job Description This position: The Manufacturing Technician II reports to a Process Execution Team Manufacture Supervisor on the Manufacturing floor, which supports Formulation operations. The position requires operating equipment in various controlled/non-classified and classified areas, product sampling, line clearances, data collection and completing batch record entries. In addition, the Technician will perform setup of equipment, direct product sampling activities and perform batch reconciliation and accountabilities per cGMPs. The Technician will also serve as a resource for the implementation of continuous improvement projects. **This position is a day shift position working 06:00 - 18:30 on a 2-2-3 rotating shift. Job Responsibilities (Including Key Result Areas, Specific Accountabilities, Tasks, Etc.) * Monitor process execution activities to ensure successful operations on the production floor. Typical duties include attending daily Tier 0 meetings, monitoring material and supply levels, and coordinating production tasks such as batch execution. * Work collaboratively with mechanic technicians and lead technicians to resolve production-related issues such as batch set-up, execution, documentation, equipment operations, SOPs, and safety and quality inspection procedures. * Perform clean in place and steam in place of process lines per SOPs. * Perform, set up, and create single use connections including single use bags. * Perform and execute filter integrity testing as needed per SOP. * Perform parts washing of parts as necessary. * Perform dispensing operations as necessary. * Perform inventory control, which will require the use of SAP. * Responsible for start-up, equipment operation, batch execution, material handling, cleaning, housekeeping and line clearance activities * Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Perform batch record and GMP documentation entries. Assist others to complete documentation as required. This will include mathematical computation where needed. * Knowledge of light material handling equipment. * Working knowledge of automated and semi-automated equipment (pumps, mixers, etc). * Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. * Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Other Responsibilities * Support lean activities such as performing 5S in the work area, participating in problem-solving, and process improvement analysis. * Responsible for assembling, disassembling, and sanitizing various equipment. * Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties. * Be flexible in cross training and support other work areas as needed. * Assist technical staff as required with preventive maintenance procedures * Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed. Competencies/Job Requirements * Acquire and maintain all required certifications and qualifications for the assigned work area * Good organizational skills, situational leadership, and decision-making skills * Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team * Ability to work e

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary & Responsibilities The Manufacturing Technician II reports to a Process Execution Team (PET) Supervisor/Manager on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified and Classified areas. The Filling Technician operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs. ** This position operates on a 2-2-3 schedule, 12 hours shifts. Night Shift position working 6:00 pm - 6:30 am, Day shift position working 6:00 AM -630PM. This position may also include the following conditions: * Perform the duties of operating assigned machinery consisting of servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product. * Responsible for assembling, disassembling, operating and sanitizing various Filling equipment. * Perform and execute filter integrity testing as needed per SOP * Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. * Be able to start up and make minor adjustments to machinery * Computer on-line may require some data input. This includes SCADA and HMI entries. * Perform visual and physical checks of in-process and finished materials as requested. * Work with various printing devices including printing mats. * Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed * Knowledge of product security controls and material handling equipment. * Responsible for outgoing quality level * Understand aseptic behaviours, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment * Perform inventory control and reconciliation activities, which may require the use of SAP in a limited role * Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. * Be familiar with "Material Safety Data Sheets" for area chemicals * Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator. * Assist mechanical staff with preventive maintenance procedures, as required. * Support lean activities and process improvement work such as performing 5S in the work area and Single Minute Exchange of Die (SMED), participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis. * Assist with executing Validation/Engineering protocols for processes/equipment. * Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise * Be flexible in training and support other Filling functions as needed. * Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed. * Acquire and maintain all required certification and qualifications for the assigned work area. * Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team. * Ability to work effectively in a team environment * Candidate shoul

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Process Engineer III, MSAT independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion and commercial introduction, serving as the primary technical escalation point for complex process issues. This role coaches Process Engineer I/II staff and partners cross-functionally with Validation, PMO, Supply Chain, Operations, and Quality. Job Responsibilities Technology Transfer & Process Engineering : Independently owns all technical aspects of assigned technology transfers from feasibility through PPQ completion, ensuring process capability at each phase gate. Leads continuous improvement workstreams across multiple assigned processes- including changeover reduction, yield improvement, OEE improvement, maintenance reliability, and waste reduction -,applying structured problem-solving (e.g., DMAIC, RCA) to drive improvements. Authors and independentlyapprovesURS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports for assigned process areas. Independently manages engineering projects from initiation to completion, including project justification, resourcing, timelines, and capital planning input. Coordinates and supports Manufacturing/Facility improvement initiatives that define equipment data, capabilities,utilization, and efficiencies; manages the equipment life cycle, including obsolescence planning. Continuous Improvement & Risk Management: Independently leadschangecontrol development and implementation, evaluating cross-functional impact and applying risk-based judgment. Performs andmaintainsrisk management activities for assigned processes and equipment using structured risk assessment tools. Initiates deviations and leadscomplextechnical investigations across multiple processes, defining CAPAs and assessing impact. Leads complex technical troubleshooting across multiple assigned processes, developing systematic approaches to recurring issues. Documentation & Compliance: Authors, reviews, and independentlyapprovescontrolled documents (SOPs, Batch Records, Rework procedures) for assigned process areas. Authors, reviews, and independentlyapprovesvalidation and change control documents, including master plans, protocols, and summary reports. Leads validation activities and periodic reviews- including validation requiredas a result ofchanges tovalidatedprocesses,evaluating compliance status and driving corrective actions. Training & Development: Coaches and mentors Process Engineer I and II staff on technology transfer, GMP practices, and problem-solvingmethodology. Independently manages external technical relationships with equipment and material suppliers, evaluating solutions and resolving issues. Designs and delivers technical training programs for Operations, Engineering, and Maintenance. Serves as key technical contact for regulatory inspections;participatesin annual product review and biennial critical systems review. Education & Experience Minimum Qualifications: Demonstrated GMP experience in a regulated pharmaceutical manufacturing environment, withability to independently apply controlled procedures andquality standards. Training or experience in one or moreof the following applicableMSAT-relevant technology areas: programmable logic controllers, computerized systems, vision systems, aseptic/controlled environment, formulation, aseptic filling, assembly, packaging, process validation, technology transfer, change control. Demonstratedproficiencyinmore thanone ofthe following disciplines: automation/controls, prep, formulation, aseptic filli

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Job Summary This Quality Technician IIautonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. The position requires operating equipment in various classified/non-classified areas up to a Class 100 aseptic environment and in a laboratory setting. This position autonomously performs tasks related to environmental monitoring to support regulatory requirements of a sterile manufacturing site. Job Responsibilities Prepare documentation of activities, actions, and results. Ensure proper documentation practices during job activities. Read SOPs (Standard Operating Procedures) and excerpts from technical documentation Maintain accurate and complete records (i.e., laboratory notebooks, quality records, and sample receipts) Complete required training Perform visual inspections Use the Environmental Monitoring System to collect and analyze samples Guide others on SOPs (Standard Operating Procedures), control documents, and/or other work instructions. Coordinate activities of support groups Ensure that others carry out laboratory duties in a manner consistent with cGMP Perform regular audits of SOPs (Standard Operating Procedures) and/or work instructions Perform routine sampling activities and associated data entry Wear gowning, sterile garments, and PPE (Personal Protective Equipment) as required by specific activities Read and interpret diagrams, drawings, and other schematics Recommend and initiate activities to ensure area and equipment is maintained in a state of compliance Provide feedback on service and quality issues on a timely basis Hours (Night Shift): 6pm - 6:30am 2/2/3 Schedule (12-Hour Rotating) Minimum Qualifications Prior experience in a pharmaceutical production environment Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language Thorough attention to detail is required Must be capable of keeping accurate records and performing mathematical calculations Preferred Qualifications High school graduate, vocational school graduate, or equivalent Working knowledge of MODA, Microsoft applications, SAP, KRONOS Experience working in a LEAN manufacturing environment Knowledge of cGMPs and FDA policies/procedures The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com The Manufacturing Technician II is a direct labor position reporting to a Process Execution Team (PET) Process Facilitator on the Manufacturing floor, which supports Filling operations. This position will require working in various Controlled/Non-Classified and Classified areas. The Filling Technician operates equipment, performs in-process monitoring, line clearances, OEE data collection, cosmetic inspection, cleaning and completes batch record entries in accordance with cGMPs. These openings are on a 12 hour day shift or night shift, which operate on a 2-2-3 schedule. (6am - 6:30pm or 6pm - 6:30am) Job Responsibilities Perform the duties of operating assigned machinery consisting of servicing filling machines with materials, removing finished materials from machine tables, and assuring the smooth flow of product. Responsible for assembling, disassembling, operating and sanitizing various Filling equipment. Perform and execute filter integrity testing as needed per SOP. Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. Be able to start up and make minor adjustments to machinery. Computer on-line may require some data input. This includes SCADA and HMI entries. Perform visual and physical checks of in-process and finished materials as requested. Work with various printing devices including printing mats. Perform batch record and GMP documentation entries. Maintain records and/or logs as required in the performance of job responsibilities. This will include mathematical computation where needed. Knowledge of product security controls and material handling equipment. Responsible for outgoing quality level. Understand aseptic behaviors, media fills including line interventions, and have a basic knowledge of viable and non-viable monitoring equipment. Perform inventory control and reconciliation activities, which may require the use of SAP/WES in a limited role. Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Be familiar with "Material Safety Data Sheets" for area chemicals. Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, waste handling, chemical handling, and spill controls. Report all discrepancies to process facilitator. Assist mechanical staff with preventive maintenance procedures, as required. Support lean activities and process improvement work such as performing 5S in the work area and, Single Minute Exchange of Die (SMED), participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis. Assist with executing Validation/Engineering protocols for processes/equipment. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise. Be flexible in training and support other Filling functions as needed. Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed. Acquire and maintain all required certifications and qualifications for the assigned work area. Capable and motivated to learn new skills and develop new capabilities on an on-going basis to contribute to the success of the Process Execution Team Ability to work effectively in a team environment. Candidate should possess the ability to work in and adapt to a changing/demanding environment. Some overtime may be required wi

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary This position is responsible for all QA activities that directly support execution of the process both within the Inspection, Assembly, Packaging (IDAP) operations, and in assigned areas outside of IDAP. These activities may include, but are not limited to, batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions. At this level the incumbent is not necessarily performing all the essential job functions of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role. Job Responsibilities * Maintain a high level of understanding of relevant production processes and quality systems * Perform the QA review and approval of the following GMP documentation that has direct impact on the activities performed by, and facilities utilized in their corresponding areas as applicable: Change Requests Batch Records and associated documentation Product and Component Release transactions in SAP Quality Investigations (Deviations, Product Complaints) Validation Plans, Protocols and Reports Standard Operating Procedures * Collaborate with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems * Execute QA processes including batch record review, product disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives * Interface with applicable site support groups on projects (capital and non-capital) that impact the IDAP/assigned area, and proactively ensure GMP compliance during the planning, execution, and closeout phases of these projects * Collaborate with and influence other IDAP/assigned area members to facilitate process improvements and risk assessments; benchmark internal and external QA practices to identify innovative efficient and effective practices * Stay abreast of evolving regulatory compliance practices and recommend implementation strategies to site leaders * Collaborate in data analysis and report creation on quality metrics and key performance indicators Hours (Night Shift): 6 PM-6 AM 2 nights on, 2 nights off, 3 nights on, 3 nights off and the rotation starts over Minimum Qualifications Experience in either the pharmaceutical industry, an operations environment, or Quality Assurance Excellent oral and written communication skills Strong ability and motivation to learn Preferred Qualifications Bachelor's degree; master's degree in science is desirable Previous experience in a Lean, process-centric organization with an emphasis on continuous improvement Multi-site / multi-functional experience The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments. Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Summary The Lead Technician reports to a Manager/Supervisor on the Manufacturing floor, which supports Inspection operations. This position will require working in various Controlled/Non-Classified areas. This position is a night shift position working 18:00 - 06:30 on a 2-2-3 shift. The Lead Technician leads the execution of batch activities on the manufacturing floor, which includes leading daily Tier 1 meetings, assigning daily tasks to production technicians, managing batch documentation, and coordinating production tasks and turnover activities. In addition, the Lead Technician will execute training for Inspection Technicians, conduct batch reconciliation and accountabilities per cGMPs, and perform the role of an Inspection Technician as needed. The Lead Technician will also serve as a resource for the implementation of continuous improvement projects. Responsibilities Lead and monitor process execution activities to ensure successful operations on the production floor. Typical duties include leading daily Tier 1 meetings, assigning daily tasks to inspection technicians, monitoring material and supply levels, and coordinating production tasks such as batch execution and turnover activities. Act as a first-line resource for the team. Provide support to production technicians and mechanic technicians. Resolve production-related issues such as batch set-up, execution, technical intervention, documentation, equipment operations, line SOPs, and safety and quality inspection procedures. Perform inventory control and reconciliation activities, which will require the use of SAP and WES in a limited role. Perform technician tasks as required including start-up, equipment operation, manual packaging, batch execution, material handling, rework, quality inspection, cleaning, housekeeping and line clearance activities. Manage batch records and GMP documentation on the production floor. Review documentation for completeness and accuracy per GxP standards within established timelines. Assist and train others to complete documentation as required. Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. Ensure work requirements are followed on the production floor, in accordance with SOPs and established safety and quality procedures. Work alongside Process Facilitators and Engineers, creating an collaborative environment for all Inspection associates. Other Responsibilities Support lean activities such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis. Lead Level 0 problem-solving on process related issues and generate OPL communications as needed. Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications. Review process documents such as operational SOPs, forms and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise. Execute protocols as required as a part of equipment qualification and process validation work. Be flexible and support other work areas within the Team as needed. Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed. Competencies/Job Requirements Acquire and maintain all required certifications and qualifications f

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Position Description The Manager, Engineering will be the primary owner of all assets and is responsible for ensuring operation and maintenance of one technical process within the PET/Facility. This includes scheduling all maintenance activities, coordination of technical resources, and technical troubleshooting. This position requires extensive collaboration with Operations and other Managers as well as Engineering, and suppliers. Leads improvement initiatives as the technical expert and acts as the first line of support for all project related work. Note: This position will primarily support Inspection Operations at the West Chester Manufacturing Site. Position Responsibilities Ensure there is one validated technical process with critical process parameters, material fit for use; material specifications and operating procedures are clear and deliver a capable process. Own asset reliability, availability, PM content, effectiveness, and performance. Own life cycle management of PET/Facility assets and development of project justification and engineering proposals. Provide technical guidance, career development, and performance management for engineering and technical personnel. Ensure proper technical support (mechanical and electronic) is available for all PET/Facility activities across all shifts. Ensure documentation and systems are updated and maintained. Ensure adherence to EHS and GMP compliance and improvements Participate in risk analysis of spare parts inventory. Drive and support improvement initiatives. Maintain external technical relationships and collaborates with equipment and material suppliers. Supports technical trouble shooting. Initiate deviations of machine failures, drive root cause analysis, and perform/facilitate technical investigations and assessment of impacts including implementation of CAPAs. Identify technical training requirements of Operations/Engineering/Maintenance/Controls for new and existing processes/equipment. Works collaboratively within PET/Facility as well as with other PET Engineers and MSAT teams. Author and review documents including Standard Operation Procedures, Batch Records, Rework procedures, Material Specifications, and other forms. Author and review validation and change control documents such as master plans, protocols, summary reports, and change requests. Provide input and develop user requirements for new asset procurement. Provide input to engineering projects as a subject matter expert in maintenance, electronics, controls and automation and are consistent with engineering standards. Key contact for regulatory inspections as technical process owner. Minimum Qualifications Experience in GMP or regulated production environment Previous supervisory experience Knowledge of FDA cGMP Strong communication and leadership skills Problem solving skills Expertise in two or moreof the following disciplines: equipment, process/materials, maintenance, project delivery, automation/ controls, and validation Preferred Qualifications Bachelor of Science in Engineering, Pharmacy, related Science or business. Previous supervisory experience Strong communication and leadership skills Problem solving and project management skills Ability to challenge and adapt current approaches/ways of doing things Proven ability to work with all levels within and outside of the organization Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Brief Job Description The Lead Technician is a direct labor position on the Manufacturing floor, which supports Filling operations and report to manager/supervisor. The position leads the execution of batch activities on the manufacturing floor, requires operating equipment in various controlled/non-classified and classified areas, product sampling, line clearances, data collection and completing batch record entries. In addition, the Lead Technician will perform setup of equipment, execute training for other Technicians, direct product sampling activities and perform batch reconciliation and accountabilities per cGMPs. The Lead Technician will also serve as a resource for the implementation of continuous improvement projects. This position is a night shift position working 6:00pm - 6:30am on a 2-2-3 shift. Primary Responsibilities * Lead and monitor process execution activities to ensure successful operations on the production floor. Typical duties include leading daily Tier 0 meetings, assigning daily tasks to production technicians, monitoring material and supply levels, and coordinating production tasks such as batch execution and turnover activities. * Act as a first-line resource for the team. Provide support to production technicians and mechanical technicians. Resolve production-related issues such as batch set-up, execution, technical intervention, documentation, equipment operations, SOPs, and safety and quality inspection procedures. * Perform clean in place and steam in place of process lines per SOPs. * Perform, set up, and create single use connections including single use bags. * Perform and execute filter integrity testing as needed per SOP. * Perform inventory control and reconciliation activities, which will require the use of SAP. * Perform technician tasks as required including start-up, equipment operation, batch execution, material handling, cleaning, housekeeping and line clearance activities * Perform cleaning and housekeeping activities for assigned areas as required to maintain a cGMP environment. * Manage batch records and GMP documentation on the production floor/EBR. Review documentation for completeness and accuracy per GxP standards within established timelines. Assist and train others to complete documentation as required. This will include mathematical computation where needed. * Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. * Knowledge of light material handling equipment. * Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications. * Working knowledge of automated and semi-automated equipment. * Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls. * Support lean activities such as performing 5S in the work area, participating in problem-solving, and process improvement analysis. Lead Level 0 problem-solving on process related issues and generate One Point Lesson communications as needed. * Responsible for assembling, disassembling, and sanitizing various equipment. * Familiarity with chemical handling and spill control procedures in connection with hazardous waste pick-up duties. * Be flexible in training and support other filling functions and work areas as needed. * Assist technical staff as required with preventive maintenance procedures

A career at Resilience is more than just a job - it's an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. For more information, please visit www.resilience.com Brief Job Description The Engineering Technician supports the Process Execution Team (PET) to deliver manufacturing performance in line with the manufacturing plan. This role requires the ability to lead technical troubleshooting for all equipment used within the PET. Individuals in this position identify and implement process improvement projects as a technical expert, interacting with Operators, PET Engineers, Area Leaders, Validation, PMO and Quality. Job Responsibilities Use a variety of tools, testing and measuring equipment to complete emergency repairs, corrective repairs and preventative maintenance on equipment and systems used within the PET. Utilize appropriate Problem Solving and Troubleshooting techniques to complete equipment repairs. Monitor equipment and/or systems for performance and problem indicators. Analyze trends in data to identify root causes, solutions and/or improvements. Support deviation investigations. Assist in the development of project justification and engineering proposals , providing input for capital planning process Participate in new equipment design, providing input for the development of User Requirements, Specifications, and all documentation needed for qualification of new equipment and processes. Serve as a project resource to install new equipment, oversee equipment retrofits and upgrades, assist with executing validation protocols for processes, and/or equipment. Leads the following continuous process improvement efforts: changeover reduction, yield improvement, OEE improvements, maintenance reliability and waste reduction. Lead and coordinate investigations and studies with little supervision. Train others on systems, software, equipment, machines, procedures and/or processes. Provide leadership, development and mentoring for others. Interface with several types of equipment and systems, including but not limited to PLCs, SCADAs, HMIs, Servers, Databases, Data Historian, Visualization, and other automation equipment. Experience with network architecture, including but not limited to VLAN, Subnets and IP protocols Support PLC, IO, and vision program troubleshooting. Implement new PLC/HMI code, changing existing PLC/HMI code and monitoring backups for data integrity and compliance. Coordinate preventative (scheduled) and corrective/emergency (unscheduled) maintenance of equipment, systems, and/or facilities without supervision. Perform work requirements in a responsible manner, in accordance with SOPs, cGMPs and established safety procedures in accordance with OSHA requirements and guidelines. Perform other similar and related responsibilities as assigned by area management. Some overtime will be required with prior notice to support business needs. Emergency overtime may be required with little notice to ensure operation of equipment within the PET. On-call support as required Hours (Day Shift) 6am - 6:30pm 2days on, 2 days off, 3 days on, 3 days off and the rotation starts over again Minimum Qualifications Experience in a regulated production environment, specifically responsible for equipment maintenance and performance Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language. Experience and knowledge of ladder logic Proficient with Computerized Maintenance Management Systems such as SAP. Able to complete documentation and required functions within the work order system. Follow and maintain compliance with established MRO procedures for inventory control. The ability to lift and handle equipment chan