Process Engineer III - Serialization

Resilience•West Chester, OH

1d•Onsite

About The Position

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.

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
Ability to analyze data and implement process improvements

Nice To Haves

Experience with automated inspection/packaging equipment preferred
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)

Responsibilities

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
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
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