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.
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.
Demonstrated experience leading investigations, root cause analysis, and change control processes.
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.
Sponsorship or support for work authorization, including visas, is not available for this position.
Resilience offers employees a robust total rewards program i
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 - 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.
Resilience · - OH - West Chester