CQV Engineer

Join a leading pharmaceutical manufacturer as a CQV Engineer supporting key capital and equipment lifecycle projects. You'll ensure systems and equipment within Sterile Fill-Finish operations are qualified, compliant, and performing at their best - safely, on schedule, and to GMP standards.

Key Responsibilities

• Lead and support full equipment validation lifecycles - from design and qualification through to ongoing validation maintenance.
• Develop and implement validation and qualification plans, including FAT/SAT, IOQ, PQ, and risk assessments.
• Support development of URS and QRAES documentation for equipment and automated systems.
• Coordinate commissioning and qualification activities across utilities, formulation, filling, and inspection systems.
• Drive continuous improvement of CQV processes and ensure adherence to quality, safety, and regulatory requirements (ICH/ASTM/GMP).
• Collaborate closely with Engineering, Manufacturing, and external vendors to ensure Quality by Design principles are applied.
• Contribute to audits, inspections, and change control activities, maintaining accurate SOPs and documentation.

Qualifications & Experience

• Degree in Engineering, Science, or related discipline.
• 6+ years' experience in Commissioning, Qualification, and Validation within pharma or biotech manufacturing.
• Strong knowledge of risk-based CQV methodologies and GMP compliance.
• Proven background qualifying sterile/biotech equipment, especially in fill-finish and utility systems.
• Familiarity with safety and environmental regulations, and experience supporting regulatory inspections.