Commissioning & Qualification (C&Q) Lead

Critical Capabilities

• Create, own, and implement the C&Q strategy, plans, and schedules for the assigned program.
• Define system boundaries, system classification, and the commissioning and qualification scope and turnover package structure.
• Forecast C&Q resource demand and partner with program leadership and service providers to secure the right contingent and contract resources.
• Direct day-to-day C&Q execution in the field through C&Q firms and contingent C&Q node leads.
• Review and accept mechanical completion (MC) turnover from construction management and C&Q firms, and drive closeout of punch list items with C&Q firms and SWAT teams.
• Coordinate pre-commissioning activities including utility priming, instrument calibration, automation downloads, installation of consumables, and VFD setup.
• Coordinate across nodes and with site utilities on demand for temporary power and utilities, and on wastewater discharge and loading of drains and sumps.
• Partner with the mechanical and construction teams on lock-out/tag-out (LOTO) and the transition of systems from construction control to commissioning control.
• Plan and lead Factory Acceptance Testing (FAT) for the program.
• Author, review, and approve commissioning and qualification protocols, test scripts, deviations, and summary reports.
• Ensure structured capture and turnover of engineering and asset information through Project Information Management (PIM).
• Lead or support system handover to the User team and Site Operations.
• Ensure C&Q activities meet regulatory, corporate, and site quality requirements.
• Manage C&Q change and deviation processes, including impact assessment against the approved scope and escalation of compliance risk.
• Enforce a strong safety culture by ensuring all commissioning and qualification activities comply with site safety standards and industry best practices.
• Serve as the program's C&Q subject matter expert, providing technical direction and coaching to contract and contingent C&Q resources.
• Identify opportunities to improve C&Q practices across the program, driving efficiency while maintaining compliance.

Qualifications

• Bachelor's in Engineering, Life Sciences, or a related field.
• 15+ years of commissioning, qualification, and validation (CQV) experience in GMP-regulated environments, including leading C&Q execution on capital projects.
• Demonstrated hands-on experience across the validation lifecycle – commissioning, qualification, systems turnover, startup support, and handover to operations.
• Experience planning and executing Factory Acceptance Testing (FAT) with equipment vendors.
• Ability to travel, both within and outside the US as required, approximately 35% expected; site-based program assignments may require extended field deployment.