Lead small-to-medium engineering projects, including equipment upgrades and process improvements
Support new product introductions (NPI) and technology transfers into manufacturing
Interface with external vendors and integrators for system support and enhancements
Mentor junior engineers and provide technical guidance across the team
Serialization Systems SME
Act as the site SME for serialization systems, including aggregation, vision systems, and data management platforms
Troubleshoot serialization equipment and software issues, coordinating with vendors and IT as needed
Lead and support serialization-related deviations, CAPAs, and change controls
Develop and maintain SOPs, work instructions, and training materials related to serialization processes
Support audits and inspections by regulatory agencies and clients
Manufacturing Line Support
Provide daily engineering support for an assigned low-volume production line
Troubleshoot equipment and process issues to minimize downtime and maintain production schedules
Lead or support root cause investigations and implement corrective actions
Drive continuous improvement initiatives focused on safety, quality, and efficiency
Collaborate with Operations, Quality, Maintenance, and Supply Chain to ensure smooth execution of production
Support process validation activities, including IQ/OQ/PQ and continued process verification
Requirements
Hands-on experience with serialization systems (e.g., vision systems, aggregation, Level 2/3 systems)
Strong knowledge of GxP environments and regulatory requirements (FDA, EMA)
Experience with validation (IQ/OQ/PQ), change control, and deviation management
Experience with automated inspection/packaging equipment preferred
Ability to analyze data and implement process improvements
Bachelor's degree in engineering (Mechanical, Chemical, Biomedical, or related field)
Experience in contract manufacturing organization (CMO/CDMO) environments
5-8+ years of experience in pharmaceutical or medical device manufacturing (contract manufacturing preferred)
Familiarity with serialization platforms (e.g., Systech)
Sponsorship or support for work authorization, including visas, is not available for this position.
Benefits
Health insuranceDental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
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 - Serialization serves as the subject matter expert (SME) for serialization systems while providing engineering support for a designated low-volume pharmaceutical production line. This role is responsible for ensuring reliable operation, compliance, and continuous improvement of serialization processes in alignment with regulatory requirements, while also driving performance, quality, and efficiency on the assigned manufacturing line.
Resilience · - OH - West Chester