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

Role: Associate Director of Commissioning and Start-Up, leading operational activities for new manufacturing facilities, expansions, and system integrations in a highly regulated biopharma environment. Responsibilities: oversee commissioning, qualification, validation, risk assessments (e.g., HAZOP), and start-up processes to ensure GMP readiness; develop and execute strategies, schedules, and protocols; partner cross-functionally with engineering, validation, quality, EHS, automation, and project teams; manage project risks, budgets, timelines, and issue resolution; support site walkdowns, troubleshoot during startup, and lead operational readiness to enable seamless transition into routine GMP production. Qualifications: Bachelor’s in Engineering, Pharmaceutical Sciences, or related field; 10-12+ years of experience in pharmaceutical or biotech manufacturing, including commissioning, qualification, validation, or operational readiness; proven leadership in cross-functional teams within GMP-regulated environments; strong project management and communication skills. Preferred: experience supporting facility expansions, biologics, sterile injectables, risk-based CQV, digital systems, and global or matrixed team leadership. High-value specifics include focus on large-scale manufacturing with a potential travel requirement to project sites, emphasizing compliance, operational excellence, and stakeholder collaboration across site leadership, engineering, validation, quality, EHS, automation, and supply chain functions.