Senior Leader, GMP Start-Up & Commissioning

AbbVie; North Chicago (IL); On-site; USD 160,000 - 210,000; Full time

Job summary

AbbVie in North Chicago, IL is seeking an Associate Director, Commissioning and Start-Up to lead commissioning, qualification, and start-up activities for new manufacturing sites, expansions, and related systems. You will ensure assets are delivered safely, compliantly, and on schedule for GMP operations.

In this role you will lead cross-functional teams and external partners, develop strategy, oversee risk, budgets, and schedules, and drive successful integration of new assets into routine site

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or related field is required; advanced degree preferred.
• Typically 10–12+ years of relevant experience in pharmaceutical/biotech manufacturing and engineering.
• Broad experience in commissioning, qualification, start-up, validation, or operational readiness.
• Demonstrated experience leading cross-functional teams and driving execution in a matrixed organization.
• Strong track record in GMP-regulated environments with excellent project leadership and communication skills.
• Ability to influence and drive alignment across functions and business units.

Responsibilities

• Provide leadership for commissioning, qualification, and start-up activities across facilities and supporting systems.
• Develop program strategy and lead detailed execution of Hazard and 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 and quality 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.
• Oversee site walkdown processes and equipment installations for accuracy and readiness.
• Lead troubleshooting and action efforts during startup to ensure successful implementation.
• Lead operational readiness and integration of new assets into routine site operations.
• Support budgeting and resource planning for commissioning and start-up efforts.

Skills

Cross-functional leadership

Project leadership

Communication skills

Influence and alignment

Multi-priority management

Matrixed organization experience

Education

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

Advanced degree preferred

Job description

AbbVie in North Chicago, IL is seeking an Associate Director, Commissioning and Start-Up to lead commissioning, qualification, and start-up activities for new manufacturing sites, expansions, and related systems. You will ensure assets are delivered safely, compliantly, and on schedule for GMP operations.

In this role you will lead cross-functional teams and external partners, develop strategy, oversee risk, budgets, and schedules, and drive successful integration of new assets into routine site