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.