Associate Director, Commissioning and Start-Up Engineering (BDS)

AbbVie

Associate Director role leading commissioning, qualification, and start-up operations for new manufacturing facilities and equipment at a pharmaceutical company. Ensures regulatory compliance and operational readiness while managing cross-functional teams and external partners throughout project execution and transition to stable operations.

Responsibilities

Lead commissioning, qualification, and start-up activities for facilities, utilities, equipment, and supporting systems
Develop program strategy and execute HAZOP studies and commissioning plans across capital projects
Ensure systems meet GMP readiness with regulatory, quality, safety, and company standard compliance
Coordinate across engineering, validation, manufacturing, quality, and external contractors for integrated execution
Manage risks, timelines, budgets, and troubleshooting during startup and operational integration phases

Requirements

Bachelor's degree in engineering, pharmaceutical sciences, life sciences, or related technical field
10-12 years minimum relevant experience in pharmaceutical/biotech or regulated manufacturing
Broad experience in commissioning, qualification, start-up, validation, and operational readiness
Demonstrated ability to lead cross-functional teams in matrixed environments
Strong track record delivering results in GMP-regulated settings
Project leadership, organizational, and communication skills with cross-function influence capability

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Vacancy posted 5 days ago

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