Leave us your email address and we'll send you all the new jobs according to your preferences.

CQV Engineer

Posted 21 hours 51 minutes ago by Morgan McKinley

Permanent
Full Time
Other
Leinster, Ireland
Job Description

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.
Email this Job