Engineering jobs in Ohio

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

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 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 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 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 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 The Process Engineer II, will handle 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 facilities, 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. After completion of PPQ, the Process Engineer leads improvement initiatives as the technical expert and acts as the first line of support for all project related work. Responsible for maintaining a strong relationship with Technical Operations and Quality areas, as well as, collaborating within Manufacturing and the Facility and with other Engineers. Serves as the single point of contact for all technical issues. Job Responsibilities * Ensures there is 1 technical process with centerlines, critical process parameters, material fit for use, and operating procedures are clear and delivers a capable process. * Leads the following continuous process improvement efforts: changeover reduction, yield improvements, OEE improvements, maintenance reliability and waste reduction for improvement of automated pharmaceutical manufacturing equipment. * Ensures success criteria for technology transfer and validation is clear and the process is capable for the merge into the Manufacturing/Facility process. * Generates a variety of URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/ reports. * Coordinate and support Manufacturing/Facility improvement initiatives that define equipment data, equipment capabilities, utilization, efficiencies, and obsolescence. Manages life cycle of assets. * Maintain external technical relationships and collaborates with equipment and material suppliers. * Identify, develop, generate, and manage implementation of appropriate change controls to improve processes and address root causes identified in investigations. * Perform and maintain risk management activities for new and existing processes / equipment. * Initiate deviations and performs/facilitates the technical investigations and assessment of impacts. * Authors and review documents including Standard Operating Procedures, Batch Records, Rework procedures and other forms. Author, review and approve validation and change control documents such as master plans, protocols, summary reports and change requests. * Provides input and develops user requirements for new asset procurement. * Provide engineering and project management services. * Assist in the development of project justification and engineering proposals including providing input for capital planning process. * Identify and support technical training requirements for Operations/Engineering/Maintenance for new and existing processes/equipment. * Perform routine validation and periodic reviews activities. * Supports and leads technical trouble shooting. * On-call support as required. * Key contact for regulatory inspections as technical process owner. * Participates in annual product review process. * Participates in biennial critical systems review process. * Responsible for process validation required because of changes to validated processes within Manufacturing. Minimum Requirements * Training or experience in t

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

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 Process Engineer III - Inspection is a mid-level technical leader responsible for the reliability, performance, validation, and inspection readiness of automated inspection equipment within a GMP-regulated manufacturing environment. This role owns the overall strategy for automated vision and inspection systems, drives long-term performance improvements, and serves as the primary technical contact for inspection-related issues impacting product quality, compliance, and throughput. The position partners cross-functionally with Manufacturing, Maintenance, Quality, Validation, Regulatory, Technical Operations, and Facilities to ensure compliant, capable, and inspection-ready systems. Position Responsibilities Equipment Reliability & Technical Leadership Own reliability strategy for automated inspection systems, ensuring sustained performance against established KPIs (OEE, False Rejects, Defect Rates, MTBF, MTTR, downtime). Develop and maintain preventive and predictive maintenance strategies for inspection equipment, including vision systems, cameras, sensors, and reject mechanisms. Analyze performance, reject rate data and trends to identify failure modes, implement corrective and preventive actions, and implement vision recipe improvements. Lead complex troubleshooting efforts for mechanical, electrical, controls, and vision-related issues. Serve as the technical subject matter expert (SME) for automated inspection system. Provide mentorship and technical guidance to engineering, maintenance, and operations teams. Provide on-call technical support as required. Validation, Compliance & Inspection Readiness Ensure automated inspection systems remain in a validated and inspection-ready state in accordance with FDA and global regulatory expectations. Author and/or approve URS, FAT/SAT protocols, commissioning documentation, and IQ/OQ/PQ protocols and reports related to inspection equipment. Support validation lifecycle activities, including revalidation following changes or performance drift. Lead technical investigations for inspection-related deviations, non-conformances, and customer complaints. Support Change Control activities, ensuring appropriate risk assessments and validation impact evaluations. Serve as inspection equipment SME during regulatory inspections and internal audits. Continuous Improvement & Asset Strategy Lead long-term reliability and performance improvement initiatives focused on: False reject reduction Detection capability optimization Equipment downtime reduction OEE improvement Obsolescence management Inspection process improvements (i.e. SOR/EOR) Implement data-driven monitoring strategies and statistical analysis to ensure sustained inspection effectiveness. Support new equipment installations, upgrades, and lifecycle planning. Drive continuous improvement initiatives using Lean and Six Sigma methodologies. Minimum Qualifications Significant experience supporting automated inspection or vision systems in a GMP-regulated manufacturing environment. Experience with equipment validation (IQ/OQ/PQ) and lifecycle management. Experience leading technical investigations, root cause analysis, and change control processes. Strong understanding of equipment reliability principles (MTBF, MTTR, FMEA, risk management). Preferred Qualifications Bachelor's degree in engineering (Mechanical, Electrical, Controls, Biomedical, or related discipline). Experience with automated vision systems, camera-based inspection platforms, and PLC/controls troubleshooting. Experience supporting reg

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 Process Engineer III - Packaging is a technical leader responsible for validated packaging processes supporting combination products and pharmaceutical-device systems within a GMP-regulated manufacturing environment. This role leads the long-term strategic packaging initiatives and provides advanced technical support to Packaging Engineers and Operations. The position serves as the primary technical contact for packaging-related issues and partners cross-functionally with Manufacturing, Quality, Validation, Regulatory, Technical Operations, Supply Chain, and Facilities to ensure compliant, efficient, and inspection-ready packaging processes. Key Responsibilities Process Ownership & Technical Leadership Own validated primary and secondary packaging processes, including serialization and aggregation systems where applicable. Ensure control of critical process parameters (CPPs), critical quality attributes (CQAs), and established operating ranges. Maintain packaging processes in a state of control through continued process verification and performance monitoring. Serve as the technical subject matter expert (SME) for automated and semi-automated packaging lines (cartoning, labeling, blistering, pouching, case packing, serialization systems, etc.). Lead complex troubleshooting and root cause investigations for packaging deviations and line performance issues. Provide mentorship and technical guidance to Packaging Engineers and Operations teams. Provide on-call support as required. Validation & Compliance Author and/or approve URS, FAT/SAT documentation, commissioning plans, and IQ/OQ/PQ protocols and reports for packaging equipment. Lead packaging process validation and revalidation activities. Initiate and lead investigations related to deviations, non-conformances, serialization discrepancies, and packaging complaints. Support and manage change control activities, ensuring appropriate risk assessments and validation strategies. Serve as technical SME during regulatory inspections and audits. Continuous Improvement & Strategic Projects Lead long-term capital and packaging line improvement initiatives focused on: OEE optimization Yield improvement Scrap and material waste reduction Changeover time reduction Serialization and aggregation efficiency Line reliability and uptime improvement Support new product introductions (NPI), artwork updates, and packaging component changes. Manage lifecycle planning and obsolescence strategies for packaging equipment and serialization systems. Support technology transfers and line expansions. Cross-Functional Collaboration Partner with Quality, Regulatory Affairs, Serialization/IT teams, Supply Chain, Manufacturing, and Facilities. Collaborate with packaging material suppliers and equipment vendors to resolve technical issues and enhance material compatibility and machine performance. Provide technical input for packaging component specifications and supplier qualifications. Support capital procurement and supplier FAT activities. Minimum Qualifications Significant experience in pharmaceutical or combination product packaging within a GMP-regulated environment. Experience with automated packaging equipment and line integration. Experience with process validation (IQ/OQ/PQ) and lifecycle validation principles. Demonstrated experience leading investigations, root cause analysis, and change control processes. Preferred Qualifications Bachelor's degree in engineering (Mechanical, Chemical, Industrial, Biomedical, or related discipline). Experience with serializa

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 manufacturing intelligence and automation systems for an Inspection, Device Assembly, and Packaging facility. The engineer will provide change management and lifecycle analysis for systems within their area of expertise. This position will be located at our Blue Ash facility. 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 guidelines. 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 Requirements Significant experience supporting manufacturing operations in a regulated or cGMP environment Experience with the following Automation systems (PLC, HMI, SCADA): Rockwell, Inductive (Ignition), or Siemens (Desigo CC) Preferred Background Bachelor's degree in engineering, computer science, or a related discipline 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 GMP principles (change control, deviation, CAPA, validation, and qualification) 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 CSV Engineer III independently plans, executes, and leads validation activities across facility, utility, process, cleaning, automation, and computer systems, with deep specialization in automation and computer system validation (CSV). Working within the process team concept, the role applies independent technical judgment to resolve complex validation challenges, requires no instruction on routine work, and partners across engineering, quality, and operations to keep systems compliant and inspection-ready. As a technical advisor to the validation function, it coaches less-experienced team members and builds alignment on validation strategy and approach. Job Responsibilities Validation Execution & Technical Leadership Independently plan, author, and execute validation deliverables - validation plans, protocols (IQ/OQ/PQ), and summary reports - for automation and computerized systems in accordance with GAMP 5 and applicable cGMP requirements. Lead the qualification and lifecycle management of automated equipment and GxP computer systems (e.g., PLC, SCADA, DCS), including 21 CFR Part 11 and data integrity (ALCOA+) compliance. Serve as a technical advisor on validation strategy and risk-based approach across the facility, utility, process, and cleaning validation portfolio. Lead and coordinate validation studies and investigations with minimal supervision, applying independent technical judgment to resolve complex issues. Communicate project priorities, risks, and progress to the process team on a continuing basis. Identify and drive continuous-improvement opportunities in validation methodology, automation, and documentation practices. Documentation & Compliance Prepare and review validation documentation, ensuring activities, actions, and results are accurate, complete, and audit-ready. Answer compliance and process questions from cross-functional partners and serve as a subject-matter resource during regulatory and internal audits. Initiate and document appropriate corrective action when process deviations or system non-conformances occur, escalating issues beyond established procedures as needed. Maintain validated state through change control, periodic review, and requalification activities. Leadership, Coaching & Mentorship Provide technical coaching and guidance to less-experienced engineers and technicians on validation methodology and automation best practices. Build alignment across engineering, quality, and operations on validation requirements and acceptance criteria. May oversee and direct the validation activities of others within assigned projects. Experience & Education Minimum Qualifications Demonstrated experience in validation or process engineering. Demonstrated ability to independently lead validation studies and projects from planning through execution with minimal supervision. Hands-on experience with automation and computer system validation (CSV). Working knowledge of GxP regulations and validation standards for computerized systems, including 21 CFR Part 11, GAMP 5, and data integrity (ALCOA+) principles. Ability to expertly read and interpret engineering drawings, P&IDs, and system diagrams. Strong analytical skills with keen attention to detail. Strong written and verbal communication skills, including technical report writing. Strong problem-solving abilities and sound independent judgment. Ability to prioritize and manage own time and workload across concurrent projects. Ability to coach peers and provide technical guidance to less-experienced team members. Preferred Qualificatio

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 MRO Project coordinator is responsible for coordination and scheduling of all project activities related to the MRO team. This includes items related to maintenance, spare parts, engineering documentation, etc. related to asset installations and/or decommissioning. * Coordinate activities and manage schedules between project/construction execution teams and MRO to ensure timely completion of project deliverables. * Develop work packages for spare parts and maintenance strategy development. * Define and maintain the spare parts inventory, ensuring accuracy, availability, and proper linkage to equipment structures in CMMS. * Research part equivalency and document according to site requirements. * Execute all maintenance-related transactions in CMMS, including creation of spare parts, BOMs, task lists, maintenance plans, equipment and functional locations. * Assist with expedient turnaround of urgent spare part requests * Collaborate with Reliability Engineers to identify failure modes, optimize maintenance frequencies, and support reliability improvement initiatives. * Participate in the installation, commissioning, and qualification of new equipment, ensuring maintenance readiness and documentation compliance. * Ensure that all maintenance programs and related documentation meet internal quality, safety, and regulatory standards. * Support audits and inspections by maintaining accurate maintenance records and ensuring alignment with GMP and EHS requirements. * Collect and organize data associated with asset lifecycle management * Coordinate asset lifecycle management activities * Track and report KPIs relative to job responsibilities * Technical writing to include investigations, line assessments, and corrective actions. * Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable. * Author/Approve/Review/Revise/Audit SOPs, Work Instructions. * Read technical publications and manuals and write associated procedures. * Review documentation needed for qualification of equipment and processes. * Guide team on SOPs (Standard Operating Procedures) and work instructions. * Communicate policies and procedures to employees. * Ensure proper documentation is maintained to company standards. * Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on. * Participate in continuous improvement activities to drive efficiency, quality, product delivery, and safety improvement. * Attend team meetings to discuss progress, initiatives, and/or other matters. * Coordinate cross-functionally with other departments as required. * Work collaboratively within and across departments to ensure sharing of best practices and lean behaviors. * Alert others (for example: Supervisor/Manager) when problems occur outside of SOPs (Standard Operating Procedures). * Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities. Minimum Requirements * Experience in a manufacturing environment * Proficiency in MS Office (Word, Excel, etc.) * Experience in meeting facilitation Preferred Background * Bachelor's degree in an engineering related discipline * Prior experience in a regulated or cGMP environment * Experience in capital project coordination/management * Experience in Computerized Maintenance Management Systems Sponsorship or support for work authorization, including visas, is not available for this position. Resilience is an

dunnhumby is the global leader in Customer Data Science, partnering with the world's most ambitious retailers and brands to put the customer at the heart of every decision. We combine deep insight, advanced technology, and close collaboration to help our clients grow, innovate, and deliver measurable value for their customers. dunnhumby employs nearly 2,500 experts in offices throughout Europe, Asia, Africa, and the Americas working for transformative, iconic brands such as Tesco, Coca-Cola, Nestle, Unileverand Metro. Job Title: Engineering Manager Job Location: 3825 Edwards Road, #600, Cincinnati, OH 45209 (May work remotely) WHY I DO MY JOB | Job purpose To manage the delivery of solutions against agreed Objectives and Key Results (OKRs)/Objectives and Key Indicators (OKIs) together with Product Management. Typically, the solution will take the form of a smaller product or portion of a larger, more complex product. This position supervises 3 direct reports whose job titles are Engineer, Senior Engineer, and Senior Software Engineer. May telecommute 100% of the time from their home office, consistent with dunnhumby's remote work policy. WHAT I DO | Key accountabilities Manage delivery of solutions to problems with a significantly increased level of complexity (technical or organizational). Establish and maintain the right squad and processes to continually deliver quality solutions, build consensus within the squad on the approach to the solution, and ensure any impediments are removed. Create an engineering squad from scratch, ensuring that the squad delivers on their commitments as well as lead the continuous integration and continuous delivery practices within the squad. Track work in progress, make it visible, and measure the rate value that is being delivered (e.g. Burn-downs, Burn-ups). Ensure that commitments are met as agreed and facilitate the interaction with other squads for any dependency or integrations. Drive the efficiency of delivery within the squad; manage the squad to produce robust, agile code; and continually strive for zero defect, continuous delivery of working software to customers. Communicate clear objectives and career paths for the squad members; monitor and appraise performance and take appropriate action; facilitate and support the development of individuals; and recognize and nurture talent. Share knowledge with users, customers, squad members and other stakeholders; collaborate with squad members and make space for their squad to innovate; and adapt and tailor the delivery methodology to reflect the needs of the problem at hand. Implement improvements to software delivery methods within the team and demonstrate how to measure and improve the rate and quality of code delivered within teams. Optimize teams to deliver solutions to complex problems at pace. Manage resources within the constraints of the budget provided by the Product Manager. Represent the department with any software delivery related matter. Stay abreast of industry news from a variety of sources and understand how industry developments may affect team. Manage risk effectively, provide visible and consistent leadership on values and Code of Business Conduct, and act where you see issues. Protect our team by ensuring they have the skills and training needed. Job requirements: Bachelor's degree (or foreign educational equivalent) in Computer Science, Mathematics, Physics, Electronics, Engineering or related field. In addition to the degree, must have at least 6 years of experience in each of the following: Developing software utilizing at least 2 software development methodologies; Adapting and tailoring a software development methodology to reflect the needs of the organization; Managing resources within constraints provided by product manager; Metadata and data pipeline management for data discovery, lineage, and governance; Establishing data quality processes and leveraging tools/frameworks to implement monitoring, validation, an