Director, Biologics Sterile Fill Engineering

AbbVie Inc.

Durham (NC)

On-site

USD 180,000 - 260,000

Full time

6 days ago

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Job summary

AbbVie Inc. is seeking a Director Engineering Technical Expert in Durham, NC, to provide enterprise-level leadership for biologics sterile fill engineering, contamination control, and aseptic processing design across strategic investments.

The role sets technical direction and ensures robust execution across capital programs. You will partner with Quality, Validation/CQV, EHS, and external partners to drive risk-based decisions, maintain engineering governance, and enable scalable manufacturing

Qualifications

Bachelor's degree in Engineering, Science or related field.
12+ to 15+ years of relevant engineering or regulated manufacturing experience.
Experience in biologics sterile filling, Annex 1, isolators/RABS, cleanroom interfaces, sterile filtration, environmental monitoring.
Ability to operate across global functions and with external engineering partners.
Strong communication, risk management, and structured problem-solving skills.

Responsibilities

Lead technical decision-making for biologics sterile fill engineering and Annex 1 compliance.
Set and govern engineering standards, design principles and playbooks across regions and capital projects.
Provide senior leadership for strategic capital investments including new facilities and capacity projects.
Coordinate with Quality, Validation/CQV, EHS, and Operations to ensure readiness and risk management.