Our client, a leading pharmaceutical company, are hiring a CQV Engineer to support capital and equipment lifecycle projects, ensuring safe, on-schedule execution in compliance with GMP and quality standards. The CQV engineer will be responsible for Sterile Fill Finish equipment validation to maintain optimal performance and compliance. This is a contract role for 12 months.Key Responsibilities:Provide technical CQV/validation expertise across the full equipment lifecycle, from design and qualification through validation maintenance and periodic review.Coordinate qualification activities to maintain equipment and utility systems in a validated state, including development of qualification strategies and equipment family approaches.Develop and approve validation documentation (URS, QRAES, C&Q/Validation Plans, FAT/SAT, IOQ/PQ) for sterile fill-finish, formulation, inspection, and utilities in line with GMP and regulatory standards.Support safe and coordinated equipment start-up, NPI introductions, and cross-functional collaboration with Engineering, Manufacturing, and external vendors using Quality by Design principles.Ensure ongoing quality and regulatory compliance through change control, SOP maintenance, inspection support, and continuous improvement of validation lifecycle processes.Key Requirements:6+ years’ experience in science, engineering, or CQV within pharmaceutical or biotechnology environments.Third-level qualification (or equivalent) in engineering or a scientific discipline.Proven expertise managing commissioning and qualification activities for pharma/biotech projects using risk-based approaches.Hands-on experience with sterile manufacturing equipment, including filling, formulation, and utility systems.Strong knowledge of GMP, safety, and environmental regulations, with experience working in cross-functional and multi-site teams.
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