Associate Director, Commissioning and Start-Up Engineering (BDS)
About the role
Company Description: AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description: 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.
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.
Qualifications
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, or a related technical discipline required; advanced degree preferred.
- Typically, 10-12 years to 20+ 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.
Skills
- Strategic leadership
- Enterprise Mindset
- Cross-functional influence
- Accountability and decision-making
- Change leadership
- Operational excellence
- Compliance and quality focus
Benefits
- Paid time off (vacation, holidays,