Senior CQV Engineer

Join a major capital project to lead the full Commissioning and Qualification (C&Q) lifecycle for Single-Use Systems, Formulation, and associated Process Equipment. Ensure safe, timely, and GMP-compliant delivery.

Key Project Deliverables

• Lead C&Q Execution: Drive all C&Q activities, including FAT, SAT, IV, and FT generation and execution.
• Documentation: Author and manage core C&Q documents (Plan, Set to Work, Summary Report).
• Coordination & Oversight: Supervise site C&Q activities, manage daily coordination meetings, and maintain the project schedule.
• Risk & Compliance: Ensure adherence to GMP/Quality standards, manage C&Q tracking/reporting, and assist with URS and QRAES development.
• Startup: Ensure safe, coordinated equipment/utility startup.

Requirements:

• Experience: 3+ years in C&Q, Engineering, or Validation, ideally within Pharmaceutical/Biotech Capital Projects.
• Technical Focus: Deep understanding of Single-Use Systems, Formulation Equipment, and a Risk-Based C&Q Approach.
• Skills: Strong leadership, communication, and stakeholder management skills. Experience with paperless validation is a plus.
• Knowledge: Expertise in GMP, Safety, and Regulatory Requirements.