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.
Cross-Function