Process Engineer III - Packaging

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