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.
