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.
Responsibilities:
- 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.
Must-Haves:
- 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 TrackWise (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.
#J-18808-Ljbffr
Packaging Engineer in Zürich Arbeitgeber: Actalent
Actalent ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Burnsville, Minnesota, eine dynamische und kollaborative Arbeitsumgebung bietet. Mit einem starken Fokus auf technische Exzellenz und kontinuierliche Verbesserung ermöglicht das Unternehmen seinen Mitarbeitern, an innovativen Projekten im Bereich der Luft- und Raumfahrttechnik zu arbeiten und sich beruflich weiterzuentwickeln. Die angebotenen Vorteile, einschließlich flexibler Arbeitszeiten, umfassender Gesundheitsleistungen und einer 401(k)-Rentenplanung, tragen dazu bei, dass Mitarbeiter sich geschätzt und unterstützt fühlen.
