Process Engineer III - Packaging

About the role

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.

Responsibilities

• 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.

Qualifications

• 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.

Preferred Qualifications

• 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.