Director, Commissioning and Start-Up Engineering

Role: Senior leadership position overseeing commissioning, qualification, and start-up strategies for major capital projects, facility expansions, and manufacturing operations in a highly regulated biotech environment. Responsibilities: develop and execute comprehensive commissioning and start-up plans; lead hazard analysis and site readiness assessments; manage cross-functional teams across Engineering, Validation, Quality, Operations, and EHS; oversee utilities, process systems, automation, and infrastructure readiness; ensure compliance with cGMP, regulatory, and safety standards; manage third-party contractors and partner with site leadership for smooth transition to operational phase; promote continuous improvement and risk mitigation; influence budgets and resources; serve as escalation point for project risks and start-up issues. Qualifications: Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; 20+ years in pharma/biotech manufacturing and engineering; extensive experience leading facility start-ups, validation, and commissioning for complex plants; strong knowledge of cGMP, regulatory expectations, EHS standards, and manufacturing quality systems; proven ability to lead large teams and manage multiple stakeholders; excellent project management, communication, and leadership skills. Preferred: Experience with sterile injectables, biologics, API, or oral solid dose manufacturing; digital systems, risk-based CQV, global project portfolios; certifications like PMP, Lean, Six Sigma. Work environment involves travel to sites and extended hours during critical phases. Internal stakeholders include site leadership, engineering, validation, quality, EHS, automation, maintenance, project management, procurement, HR, and finance.