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Director, Engineering, Technical Expert Sterile Fill

AbbVie · North Chicago, IL

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Role summary

AbbVie seeks a Director of Engineering to provide enterprise-level technical leadership for sterile fill operations across its strategic investment portfolio. The role establishes engineering standards, governs capital programs for biologics manufacturing facilities, and ensures compliance with EU GMP Annex 1 requirements for aseptic processing and contamination control.

What they're looking for

  • Extensive experience in sterile fill engineering and biologics manufacturing operations
  • Deep knowledge of EU GMP Annex 1 requirements and aseptic processing design
  • Proven track record leading capital programs and facility builds in pharmaceutical manufacturing
  • Expert-level understanding of contamination control strategy and barrier technologies
  • Strong experience with validation, CQV integration, and GMP readiness assessments
  • Demonstrated ability to establish technical standards and drive enterprise alignment across organizations

What you'll be doing

  • Establish and deploy global engineering standards for sterile fill, aseptic processing, and Annex 1 compliance
  • Provide senior technical leadership for strategic capital investments including new facilities and technology platforms
  • Govern technical decisions on isolators, barrier systems, cleanroom design, and contamination control strategies
  • Partner with Quality, Operations, and Validation teams to ensure sterile fill programs achieve inspection readiness and product sterility assurance
  • Drive consistent application of lessons learned and engineering playbooks across regions and capital projects

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted15 days ago
Last source check1 day ago
Salary listedNeeds clarity
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