Process Engineer III - Packaging

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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.

Minimum 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.

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