CQV Engineer II Job

· Lead and execute commissioning activities for equipment, utilities, and facility systems, including mechanical completion checks, system startup, and troubleshooting.

· Plan, prepare, and execute verification and qualification protocols (IQ, OQ, PQ) in alignment with project schedules and quality standards.

· Develop, review, and maintain CQV documentation (system boundaries, design review matrices, traceability matrices, commissioning protocols, qualification protocols, and summary reports).

· Coordinate with architecture and engineering (A&E) firms, OEMs, construction teams, and automation vendors for system readiness.

· Perform system walkdowns, field verifications, punch list creation, and resolve identified deficiencies.

· Ensure timely and accurate completion of equipment and system turnover packages (TOPs) according to project milestones.

· Support and participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), including vendor documentation review.

· Ensure full compliance with GMP requirements by following proper documentation practices and established procedures.

· Support risk assessments, impact assessments, and change control processes.

· Participate in client meetings, project schedule discussions, and daily coordination meetings to provide updates and escalate issues.

· Assist with CSV and automation qualification activities alongside automation engineers and system owners.

· Provide guidance, training, and onboarding support to junior team members during project ramp-up.

· Maintain and update project trackers, punch lists, and validation status reports to ensure accurate project visibility.

· Contribute to continuous improvement initiatives to enhance CQV processes, templates, and execution strategies.

Bachelor's Degree is required in Pharmacy or Pharmaceuticals Engineering or Pharmaceutical Science

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave