We are seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join a dynamic team managing capital projects and equipment lifecycles. This role focuses on equipment validation within a Sterile Fill-Finish environment, ensuring all activities are performed safely, on schedule, and in strict compliance with GMP and Quality requirements.
Key Responsibilities
- Validation Lifecycle Management: Support the full validation lifecycle from initial design and URS development through to qualification and ongoing maintenance (e.g., periodic reviews).
- Strategy & Planning: Develop qualification approaches, equipment family strategies, and validation plans (FAT, SAT, IV/FT, IOQ, PQ) for vial/syringe filling, formulation, and inspection areas.
- Safety & Compliance: Oversee the safe startup of equipment and utilities, ensuring all activities align with ICH/ASTM guidelines and site change control procedures.
- Cross-Functional Collaboration: Liaise with Engineering, Manufacturing, and external vendors to ensure Quality by Design (QbD) principles are integrated into equipment specifications.
- Continuous Improvement: Support New Product Introductions (NPI) and enhance the equipment validation lifecycle process to maintain regulatory readiness.
- Audit Support: Participate in regulatory inspections, filings, and RTQs (Response to Questions), maintaining up-to-date SOPs.
Requirements
- Experience: 6+ years in Science, Engineering, or CQV Management within the Biotechnology/Pharmaceutical industry.
- Education: Third-level technical qualification (Degree) in Engineering or Science.
- Technical Expertise: Extensive experience managing risk-based CQV for sterile manufacturing equipment (filling, formulation, and utility systems).
- Regulatory Knowledge: Strong understanding of GMP, safety, and environmental regulatory requirements.
- Soft Skills: Proven ability to work within multidisciplinary, cross-functional teams.
