Purpose The CSV Engineer has a key role in ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing. Responsibilities Integrally involved in the validation of all new computerised equipment, and control systems Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems. Participates in the change control process advising on CSV issues, as appropriate Hands on role in the development and execution of DQ, IQ, OQ and PQ activities. Ensures projects are managed in compliance with all required Company and legal requirements (Health & Safety, cGMP, construction, environmental etc). Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance. Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilisation. Ensure that the validation status of equipment and systems are in compliance with cGMP at all times. Maintain validation documentation through the Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans Generate/review/approve execution of the validation/revalidation plans Review and approval of site change controls Ensure compliance to cGMP at all times Qualifications Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec) Post-graduate studies as appropriate to augment primary Degree 3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector. 2-3 years experience in validation environment Project management experience. Capable of troubleshooting validation issues associated with projects, process development etc. Competent technical knowledge of pharmaceutical plants. Knowledge of requirements for of GAMP, ISPE Baseline guides. Full understanding of relevant quality and compliance regulations Able to execute projects to plan. Good knowledge of quality management systems. Effective facilitator. Good communication skills at organisation, team and individual levels. Understands KPIs for the site. Natural influencer and works well as part of a multifunctional team. Highly motivated and self-resilient. Adaptable and flexible as well as a pragmatically minded problem solver. Sees projects/tasks through to completion. Skills: Computer System Validation GAMP PQ DQ OQ