Associate Director, Commissioning and Start-Up Engineering (HAZOP)
About The Position
The Associate Director, Commissioning and Start-Up is responsible for providing operational leadership for commissioning, qualification, and start-up activities supporting new manufacturing sites, facilities expansion, utilities, equipment, and related systems. This role ensures assets are delivered safely, compliantly, and on schedule in a state of readiness for GMP operations, while meeting Abbvie quality, operational, and business objectives. The Associate Director leads cross-functional teams and external partners while enabling a smooth transition from project execution to sustained operational performance.
Requirements
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline required; advanced degree preferred.
- Typically, 10-12 years20+ years of relevant experience in pharmaceutical or biotech manufacturing and engineering or other highly regulated manufacturing environments.
- Broad experience in commissioning, qualification, start-up, validation, or operational readiness.
- Demonstrated experience leading cross-functional teams. Ability to manage multiple priorities, work through ambiguity, and drive execution 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.
Nice To Haves
- Experience supporting facility expansions, new product introductions, or major capital projects.
- Experience in sterile injectables, biologics, API, or oral solid dose manufacturing.
- Experience with risk-based CQV methodology and digital turnover systems.
- Prior people leadership experience in a matrixed, global, or highly collaborative 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.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- long-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Manager
