Resilience
Process Engineer III - Packaging
USA - OH - West Chester · Mid
Work authorization required$80k-$121kDetected 20 days ago
Project ManagementSupply ChainProcess ImprovementProcurementCustomer SupportGMPFDA RegulatoryLeadershipCollaborationMentoringLean ManufacturingRegulatory Affairs
About the role
- 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.
Responsibilities
- Own validated primary and secondary packaging processes, including serialization and aggregation systems where applicable.
- Maintain packaging processes in a state of control through continued process verification and performance monitoring.
- Lead complex troubleshooting and root cause investigations for packaging deviations and line performance issues.
- 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.
- Lead long-term capital and packaging line improvement initiatives focused on:
- 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.
Requirements
- 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.
- Provide on-call support as required.
Nice to have
- Bachelor's degree in engineering (Mechanical, Chemical, Industrial, Biomedical, or related discipline).
- Experience with serialization and aggregation systems.
- Experience supporting regulatory inspections.
- Project management experience in capital equipment or long-term improvement initiatives.
- Lean manufacturing or Six Sigma certification.
- Resilience is an Equal Employment Opportunity Employer.
- Requests for reasonable accommodation can be made at any stage of the recruitment process.
- Excited about Resilience?
Compensation
- Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healt
Visa & Work Authorization
- Sponsorship or support for work authorization, including visas, is not available for this position.
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This listing is sourced directly from Resilience's careers page and normalized into a canonical job model.