We are seeking an experienced C&Q Engineer to drive the commissioning, qualification, and validation lifecycle for process equipment within a state-of-the-art solid dosage manufacturing facility.
Reporting to the SRV Supervisor, you will act as the primary client-side C&Q Engineer, owning the delivery strategy, schedule, safety, and regulatory compliance from initial commissioning through to final Performance Qualification (PQ) and hand-over to Operations.
Key Responsibilities
- C&Q Strategy & Delivery: Plan, own, and execute end-to-end CQV activities for solid dosage process systems aligned with project milestones and GMP requirements.
- Vendor & Partner Management: Oversee third-party commissioning partners and contractors, ensuring quality execution against scope and programme timeline.
- Stakeholder Alignment: Act as the single point of contact for C&Q interfaces across Quality, Manufacturing, Engineering, EHS, and Operational Readiness.
- Compliance & Quality: Ensure full alignment with Science and Risk-Based Verification protocols, CSV fundamentals, GEP, and local regulatory standards (including CTOP, VTOP, test packs, and deviation management).
- Risk & Reporting: Maintain project risk registers, manage system deviations/change controls, and provide clear progress reporting to Senior Project Management.
Essential Requirements
- Experience: 7+ years in pharmaceutical commissioning and qualification, with a proven track record specifically involving solid dosage process equipment.
- Education: Degree in Engineering, Life Sciences, or equivalent industry expertise.
- Skills: Strong knowledge of GMP, the validation lifecycle, CSV fundamentals, and hands-on experience managing external commissioning contractors.
- Leadership: Exceptional stakeholder management, risk mitigation skills, and communication across all organizational levels.
