Strategic Leader, GMP Commissioning and Start-Up

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 142,000 - 269,000; Full time

Job summary

AbbVie is seeking an Associate Director of Commissioning and Start-Up Engineering (BDS) to provide operational leadership for commissioning, qualification, and startup activities across facilities and systems. The role ensures assets are delivered safely, compliant, and ready for GMP operations while meeting quality and business objectives.

The candidate will lead cross-functional teams, develop program strategies, and oversee hazard analyses (HAZOP) for capital programs, driving alignment

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related technical discipline.
• Typically 10–12 years of experience in pharmaceutical/biotech manufacturing or other highly regulated environments.
• Broad experience in commissioning, qualification, start-up, validation, or operational readiness.

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 & Operability (HAZOP) studies for 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 regulatory, quality, safety, and company standards.
• Partner cross-functionally with engineering, validation, manufacturing, quality, EHS, automation, project management, and contractors.
• Manage risks, dependencies, timelines, budgets, and issue resolution throughout the project lifecycle.
• Support site walkdown processes against as-built P&ID diagrams and equipment installations for readiness.
• Lead troubleshooting and CAPA efforts during startup to enable stable operations.
• Lead operational readiness and integration of new assets into site operations.

Skills

Cross-functional leadership

Project leadership

GMP experience

Communication

Influence & alignment

Operational excellence

Change leadership

Compliance & quality

Education

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

Advanced degree preferred

Job description

AbbVie is seeking an Associate Director of Commissioning and Start-Up Engineering (BDS) to provide operational leadership for commissioning, qualification, and startup activities across facilities and systems. The role ensures assets are delivered safely, compliant, and ready for GMP operations while meeting quality and business objectives.

The candidate will lead cross-functional teams, develop program strategies, and oversee hazard analyses (HAZOP) for capital programs, driving alignment