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.
Key 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.