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

Role: Associate Director of Commissioning and Start-Up, leading operational activities for new manufacturing sites, facility expansions, utilities, and equipment to ensure GMP readiness. Responsibilities: develop and execute commissioning, qualification, and start-up strategies; lead cross-functional teams including engineering, validation, quality, EHS, automation, and project management; manage risk, schedules, budgets, and issue resolution; oversee site walkdowns and operational readiness to support seamless integration of new assets. Qualifications: Bachelor's in Engineering, Pharmaceutical Sciences, or related field; 10-12 years of experience in pharmaceutical or biotech manufacturing, with broad expertise in commissioning, qualification, validation, and operational readiness; proven leadership in regulated environments. Preferred: experience with facility expansions, biologics, sterile injectables, risk-based CQV, and digital systems; prior leadership in global or matrix settings. HighValue: extensive GMP manufacturing experience, biologics or sterile injectable focus, capital project execution, cross-functional stakeholder management. WorkSetup: travel to project and manufacturing sites as needed, with occasional extended hours during critical startup phases.