Director, Biologics Sterile Fill Engineering – Global Impact

AbbVie Inc.; Durham (NC); On-site; USD 161,000 - 305,000; Full time

Job summary

AbbVie Inc. in Durham, NC is seeking a Director of Engineering, Technical Expert Sterile Fill to lead enterprise-level sterile fill engineering across strategic investments. You will set technical direction, govern standards and ensure robust execution across capital programs in biologics and aseptic processing.

In this role you will partner with site operations, quality, validation and external partners to drive contamination control and Annex 1 compliance, enabling safe, scalable manufacturing.

Qualifications

• Bachelor’s degree in Engineering, Science or a relevant technical discipline required; advanced degree preferred.
• Typically 12+ to 15+ years of relevant engineering, manufacturing, capital project, technical operations or regulated manufacturing experience.
• Demonstrated technical capability in biologics sterile filling, aseptic processing, Annex 1 contamination control and related areas.
• Experience supporting pharmaceutical or biologics manufacturing environments preferred.

Responsibilities

• Provide senior technical leadership for biologics sterile fill engineering, aseptic processing design and Annex 1 compliance.
• Drive engineering governance, standards and risk-management across strategic investment programs.
• Lead cross-functional collaboration with Quality, Validation/CQV, EHS, Operations and external partners.
• Ensure safe, compliant, reliable deployment of sterile fill systems across facilities.

Skills

Biologics sterile filling

Isolator / RABS

GMP readiness

Engineering governance

Technical risk management

Education

Bachelor’s degree in Engineering, Science or a relevant technical discipline

Tools

Annex 1 compliance knowledge

Job description

AbbVie Inc. in Durham, NC is seeking a Director of Engineering, Technical Expert Sterile Fill to lead enterprise-level sterile fill engineering across strategic investments. You will set technical direction, govern standards and ensure robust execution across capital programs in biologics and aseptic processing.

In this role you will partner with site operations, quality, validation and external partners to drive contamination control and Annex 1 compliance, enabling safe, scalable manufacturing.