Packaging Engineer / Packaging Technical Lead (Pharma)

• Manage packaging engineering activities across external CMOs, ensuring compliance, efficiency, and product quality.
• Own and maintain packaging-related documentation in compliance with cGMP requirements.
• Develop, review, and approve technical profile drawings, packaging specifications, purchasing specifications, and release documentation.
• Lead the qualification and implementation of new packaging components and modifications to existing packaging systems.
• Support packaging process validation activities and technical troubleshooting.
• Manage Change Controls, Deviations, Investigations, and CAPA activities using electronic quality management systems.
• Coordinate the implementation and standardization of packaging platform components across global operations.
• Maintain and manage Bills of Materials (BOMs) and related packaging master data.
• Support the qualification of alternative materials, suppliers, and manufacturing processes to mitigate supply-chain risks.
• Ensure packaging and labeling compliance with global regulatory requirements, including serialization and product authentication initiatives.
• Support product launches, lifecycle management activities, and continuous improvement projects.
• Collaborate closely with Quality, Regulatory Affairs, Manufacturing, Supply Chain, and external CMO partners.
• Drive projects independently while understanding their broader strategic and business impact.

• Bachelor's Degree in Engineering, Packaging Engineering, or a related technical discipline.
• Minimum of 5 years of experience within the pharmaceutical industry or a similarly regulated environment.
• Strong knowledge of cGMP requirements and pharmaceutical documentation practices.
• Proven experience in packaging engineering, packaging process validation, and technical specification management.
• Hands-on experience with packaging component qualification and packaging equipment.
• Fluency in English.
• Mandatory experience with TrackWise.
• Experience managing technical drawings, packaging specifications, and design changes.
• Strong knowledge of electronic quality management systems.
• Experience with Veeva or similar document management systems is highly desirable.

Interested?
I look forward to your application.