Strategic Lead, Commissioning & Start-Up Engineering

SmartRecruiters, Inc.; Durham (NC); In loco; USD 142.000 - 269.000; Tempo pieno

Descrizione del lavoro

AbbVie seeks an Associate Director of Commissioning and Start-Up Engineering (BDS) to lead global commissioning, qualification, and startup initiatives for new manufacturing sites and expansions. You will guide cross-functional teams to ensure safe, compliant, on-schedule asset readiness for GMP operations and seamless project transitions.

The role requires deep experience in pharma/biotech manufacturing, strong leadership, and the ability to drive complex programs in a matrixed environment.

Competenze

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline.
• Typically, 10–12 years of relevant experience in pharmaceutical or biotech manufacturing and engineering.
• Broad experience in commissioning, qualification, start-up, validation, or operational readiness.
• Demonstrated experience leading cross-functional teams in a matrixed organization.
• Strong track record of delivering results in a GMP-regulated environment.
• Strong project leadership, organizational, and communication skills.

Mansioni

• 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.
• 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 and resource planning for commissioning and start-up efforts.

Conoscenze

Cross-functional leadership

Project leadership

Communication skills

Formazione

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

Advanced degree preferred

Descrizione del lavoro

AbbVie seeks an Associate Director of Commissioning and Start-Up Engineering (BDS) to lead global commissioning, qualification, and startup initiatives for new manufacturing sites and expansions. You will guide cross-functional teams to ensure safe, compliant, on-schedule asset readiness for GMP operations and seamless project transitions.

The role requires deep experience in pharma/biotech manufacturing, strong leadership, and the ability to drive complex programs in a matrixed environment.