Position OverviewCommissioning, Qualification and Validation (CQV) engineer for various capital and Equipment lifecycle projects joining a dynamic team. The role will be responsible for equipment validation in Sterile Fill Finish to ensure the maximum levels of performance and compliance are maintained. All activities are to be completed safely, on schedule and in compliance with GMP and Quality Requirements.Key ResponsibilitiesProvide expert technical validation support to meet site objectives, comprising the full validation lifecycles process from initial design through qualification to validation maintenance (e.g., periodic review).Coordinate the qualification activities and maintain equipment and utility systems in a validated state.Develop or qualify approaches and equipment family strategies.Assist in the development of User Requirement Specifications (URS) and Quality Risk Assessment for equipment and automated systems (QRAES).Develop and approve C&Q / Validation Plans, FAT, SAT IV/FTs, QRAES, IOQs, PQs, etc. for the vial and syringe filling, formulation, inspection and utility areas in line with GMP, regulatory requirements and corporate standards.Ensure startup of equipment/utilities is completed in a safe and coordinated manner.Liaise with Engineering, Commissioning and Qualification, manufacturing, planning and PD and external vendors regarding equipment URS and Factory Acceptance Tests to ensure design‐by‑quality principles are followed.Support NPI introductions to equipment.Assist in the development and improvement of the equipment validation lifecycle process while ensuring continued compliance with all necessary regulations.Participate in regulatory inspections, regulatory filings and RTQs (response to questions).Update and maintain Standard Operating Procedures (SOP) in accordance with site and corporate requirements.Take ownership for quality compliance in all activities, ensuring approaches align with current guidelines (ICH/ASTM).Ensure the site change control procedure is adhered to.Education / Experience6+ years experience in Science, Engineering or Validation, Commissioning and Qualification Management.Technical qualification at third level or equivalent in Engineering or science.Extensive knowledge and demonstrated experience managing Commissioning and Qualification for pharmaceutical/biotechnology projects.Strong understanding of a risk‑based approach to commissioning and qualification within the biotechnology industry. Experience with sterile/biotech equipment within the pharmaceutical industry is preferred.Experience qualifying filling, formulation and utility systems within the sterile manufacturing environment of drug product.Knowledge of safety, GMP and environmental regulatory requirements.Participate, when required, as a member of multidisciplinary site and multisite teams, e.g., Cross Functional Investigation Team or NPI regulatory marketing applications.
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