Director, Engineering, Technical Expert Sterile Fill

AbbVie

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.

Responsibilities

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

Requirements

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

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Vacancy posted 5 days ago

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