Executive Start-Up & Commissioning Leader (GMP)

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

Job summary

AbbVie seeks an Associate Director, Commissioning and Start-Up Engineering (HAZOP) to lead commissioning, qualification, and start-up activities for new manufacturing sites and expansions. You will drive HAZOP studies, align strategies, and ensure GMP readiness across facilities, partnering with engineering, validation, quality, EHS, automation, and contractors.

The role requires a Bachelor’s in Engineering or related field with 10–12 years in pharma/biotech manufacturing or regulated settings;

Qualifications

• Bachelor’s degree in Engineering or related technical discipline required; advanced degree preferred.
• Typically 10–12 years in pharma/biotech manufacturing and engineering or other highly regulated environments.
• Broad experience in commissioning, qualification, start-up, validation, or operational readiness.
• Demonstrated experience leading cross-functional teams; ability to manage multiple priorities in a matrixed organization.
• Strong track record of delivering results in a GMP-regulated environment.
• Strong project leadership, organizational, 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, 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 regulatory, quality, safety, and company standards.
• Partner cross-functionally with engineering, validation, manufacturing, quality, EHS, automation, project management, and third-party contractors.
• Manage risks, dependencies, timelines, budgets, and issue resolution throughout the project lifecycle.
• Lead site walkdown processes against as built P&ID and Equipment installations to ensure accuracy.
• Lead troubleshooting and corrective action efforts during startup to support successful implementation and stable operations.

Skills

Cross-functional leadership

GMP experience

Project management

Strategic leadership

Change leadership

Communication

Influence across functions

Education

Bachelor's degree in Engineering/Pharma/Science

Advanced degree preferred

Job description

AbbVie seeks an Associate Director, Commissioning and Start-Up Engineering (HAZOP) to lead commissioning, qualification, and start-up activities for new manufacturing sites and expansions. You will drive HAZOP studies, align strategies, and ensure GMP readiness across facilities, partnering with engineering, validation, quality, EHS, automation, and contractors.

The role requires a Bachelor’s in Engineering or related field with 10–12 years in pharma/biotech manufacturing or regulated settings;