Director, Engineering, Technical Expert Sterile Fill

What you'll do

• Establish and maintain global engineering standards for biologics sterile fill, aseptic processing, and Annex 1 contamination control.
• Provide technical leadership for capital projects including new facility builds, technology platform deployments, and capacity expansions.
• Oversee the design of isolators, RABS, and cleanroom environments to ensure compliance with EU GMP Annex 1 requirements.
• Lead the development of contamination control strategies across facility design, equipment, utilities, and personnel flows.
• Drive technical decision-making for sterile filtration, container closure integrity, and aseptic process simulations.
• Manage risk-based decisions regarding line set-up, lyophilization interfaces, and single-use systems to ensure product sterility.
• Coordinate with cross-functional teams including Quality, EHS, and Validation to ensure manufacturing readiness and inspection readiness.
• Mentor staff and share engineering best practices to build technical capability across the global organization.

What we're looking for

• Bachelor’s degree in Engineering, Science, or a relevant technical discipline required; advanced degree preferred.
• 12 to 15+ years of experience in engineering, manufacturing, capital projects, technical operations, or regulated manufacturing.
• Demonstrated expertise in biologics sterile filling, aseptic processing, and Annex 1 contamination control.
• Experience in pharmaceutical, biopharmaceutical, medical device, API, peptide, or other similarly regulated manufacturing environments (preferred).
• Proven ability to collaborate across global functions, project teams, suppliers, and external engineering partners.
• Strong communication, risk management, technical judgment, stakeholder engagement, and structured problem-solving skills.