Director, Commissioning and Start-Up Engineering
AbbVie · Durham, NC · 1 mo ago
EngineeringFull-time
About the role
Position Summary: The Director of Commissioning and Start-Up Engineering is a senior leadership role responsible for establishing and executing commissioning, qualification, and start-up strategies for major capital projects, facility expansions, and new manufacturing operations. This role provides enterprise-level leadership to ensure assets are delivered safely, compliantly, and on schedule while meeting AbbVie quality, operational, and business objectives. The Director leads cross-functional teams and external partners through turnover, readiness, and operational handoff in highly regulated manufacturing environments.
Responsibilities
- Lead the development and execution of comprehensive commissioning and start-up strategies for major capital projects and manufacturing expansions.
- Develop program strategy and lead detailed execution of Hazard and Operability (HAZOP) Studies for all capital programs.
- Leads site walkdown processes against as built Piping & Instrumentation Diagrams along with Equipment installations to ensure accuracy and operational readiness.
- Provide strategic direction for CQV readiness, turnover governance, and transition-to-operations planning.
- Ensure commissioning and start-up activities align with AbbVie’s safety, quality, cost, and schedule expectations.
- Direct cross-functional teams across Engineering, Validation, Quality, Operations, Automation, Maintenance, Supply Chain, and EHS.
- Oversee readiness for utilities, process systems, cleanrooms, automation platforms, and supporting infrastructure.
- Establish and maintain project governance, milestone tracking, risk management, and escalation pathways.
- Drive operational readiness activities including SOP development, training, staffing readiness, maintenance planning, spare parts strategy, and documentation completion.
- Manage third-party contractors, consultants, and integration partners to ensure execution quality and accountability.
- Partner with site leadership and functional leaders to ensure successful transition from project delivery to stable operations.
- Ensure all turnover, commissioning, and start-up activities comply with cGMP, regulatory, and EHS requirements.
- Champion standardization, continuous improvement, and lessons learned across projects and sites.
- Influence budget, resource planning, and strategic priorit