Packaging Engineer

Our client is seeking an experienced Packaging Engineer to support commercial pharmaceutical packaging operations across a global product portfolio. This role will serve as a key packaging SME, managing packaging engineering activities with external CMOs and ensuring compliance, quality, and uninterrupted product supply. The successful candidate will play a critical role in packaging lifecycle management, change implementation, qualification activities, and documentation governance within a highly regulated GMP environment.

• Manage packaging engineering activities at external CMOs, including oversight of packaging-related documentation and compliance requirements.
• Lead and support the development, launch, lifecycle management, and continuous improvement of primary and secondary packaging components.
• Coordinate the qualification and implementation of new packaging components, materials, suppliers, and manufacturing processes to ensure supply continuity and risk mitigation.
• Develop, review, and approve technical drawings, packaging specifications, profiles, and purchasing/release documentation.
• Execute and support packaging process validation and qualification activities on packaging equipment.
• Own and manage change controls, deviations, non-conformances, investigations, and CAPAs in collaboration with Quality, Regulatory, and cross-functional stakeholders.
• Maintain and update Bills of Materials (BOMs) and packaging master data.
• Drive harmonization and standardization initiatives for platform packaging components across multiple markets.
• Ensure packaging solutions meet regulatory requirements, including serialization, authentication, and global labeling standards.
• Collaborate closely with internal teams and external technical experts across multiple regions and time zones to deliver projects on time and in compliance.

• Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or a related engineering discipline.
• Minimum 5 years of experience in pharmaceutical, biotech, or other highly regulated manufacturing environments.
• Strong knowledge of cGMP requirements and pharmaceutical packaging documentation standards.
• Hands-on experience with quality management systems, particularly Track Wise (mandatory); familiarity with Veeva is an advantage.
• Proven experience qualifying packaging components and packaging equipment.
• Experience creating, reviewing, and approving technical specifications, profile drawings, and packaging documentation.
• Solid understanding of packaging process validation and lifecycle management.
• Demonstrated experience managing change controls, deviations, investigations, and CAPAs.