Strategic Lead, Commissioning & Start-Up Engineering

AbbVie; Durham (NC); On-site; USD 170,000 - 210,000; Full time

Job summary

AbbVie is seeking an Associate Director of Commissioning and Start-Up in Durham, NC. You will lead commissioning, qualification, and start-up activities for new manufacturing sites and expansions, ensuring safe and compliant operations that meet project timelines.

You will manage cross-functional teams across engineering, validation, quality, and operations, drive risk management, and deliver turnkey turnover packages with rigorous adherence to GMP standards.

Qualifications

• Typically 10–12 years of relevant experience in pharmaceutical or biotech manufacturing.
• Broad experience in commissioning, qualification, start-up, validation, or operational readiness.
• Strong project leadership, organizational, and communication skills.
• Ability to influence and drive alignment across functions and business units.
• Strong track record of delivering results in a GMP-regulated environment.

Responsibilities

• Provide leadership for commissioning, qualification, and start-up activities across facilities, utilities, equipment, and supporting systems.
• Develop program strategy and lead detailed execution of Hazard and Operability (HAZOP) Studies for all capital programs.
• Develop, align, and execute commissioning and start-up strategies, plans, schedules, protocols, and turnover packages.
• Ensure readiness of systems for GMP operations in compliance with applicable regulatory, quality, safety, and company standards.
• Partner cross-functionally with engineering, validation, manufacturing, quality, EHS, automation, project management, and third-party contractors to deliver integrated startup execution.
• Manage risks, dependencies, timelines, budgets, and issue resolution throughout the project lifecycle.
• Support and oversee site walkdown processes against as built Piping & Instrumentation Diagrams along with Equipment installations to ensure accuracy and operational readiness.
• Lead troubleshooting and corrective action efforts during startup to support successful implementation and stable operations.
• Lead operational readiness and the successful integration of new assets into routine site operations.
• Support budgeting, resource planning, for commissioning and start-up efforts.

Skills

Cross-functional leadership

Project leadership

Communication skills

Influence and alignment

GMP awareness

Education

Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related technical discipline

Advanced degree preferred

Job description

AbbVie is seeking an Associate Director of Commissioning and Start-Up in Durham, NC. You will lead commissioning, qualification, and start-up activities for new manufacturing sites and expansions, ensuring safe and compliant operations that meet project timelines.

You will manage cross-functional teams across engineering, validation, quality, and operations, drive risk management, and deliver turnkey turnover packages with rigorous adherence to GMP standards.