Key Skills: Commissioning and Qualification (C&Q), CQV strategy development, FAT, pre-commissioning, construction turnover, qualification protocols, regulatory compliance, vendor management, change control, risk management, API manufacturing, 21 CFR Part 11, Kneat, and operational readiness. Preferred: Pharmaceutical/biotech experience, API manufacturing CQV, projects exceeding $100 million, Kneat or similar electronic qualification platforms, 21 CFR Part 11 knowledge and a master's degree.