Director, Biologics Sterile Fill Engineering

AbbVie; Illinois; On-site; USD 180,000 - 240,000; Full time

Job summary

AbbVie is seeking a Director Engineering Technical Expert in Sterile Fill to provide enterprise-level leadership across biologics sterile fill projects and Annex 1 alignment. You will shape engineering strategy, drive governance, and ensure readiness for major capital programs with cross-functional collaboration across sites and external partners.

The role emphasizes technical assurance, risk-based decision making and the development of reusable engineering practices to enable high-quality

Qualifications

• Experience in biologics sterile filling, aseptic processing and Annex 1 contamination control.
• Proven capability to lead technical decisions with risk-based thinking.
• Strong governance, standards development and cross-site collaboration.

Responsibilities

• Lead engineering decision-making for biologics sterile fill programs and Annex 1 compliance.
• Establish global standards and governance for sterile fill engineering and related interfaces.
• Partner with Quality, Validation, CQV and Operations to ensure readiness and compliance.
• Drive capital project delivery with safety, quality and reliability as priorities.

Skills

Sterile fill engineering

Aseptic processing

Contamination control

GMP readiness

Validation CQV

Technical leadership

Risk management

Education

Bachelor's degree required

Advanced degree preferred

Tools

Isolators/RABS

Cleanroom interfaces

Environmental monitoring

Sterile filtration

Job description

AbbVie is seeking a Director Engineering Technical Expert in Sterile Fill to provide enterprise-level leadership across biologics sterile fill projects and Annex 1 alignment. You will shape engineering strategy, drive governance, and ensure readiness for major capital programs with cross-functional collaboration across sites and external partners.

The role emphasizes technical assurance, risk-based decision making and the development of reusable engineering practices to enable high-quality