Purpose of Role The CSV Engineer has a key role in ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing. ResponsibilitiesIntegrally involved in the validation of all new computerised equipment, and control systemsGenerates 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 appropriateHands on role in the development and execution of DQ, IQ, OQ and PQ activities.Ensures projects are managed in compliance with all required *** 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 theApproval and implementation of changes to relevant systems and assist in generating validation/ revalidation plansGenerate/review/approve execution of the validation/revalidation plansReview and approval of site change controlsEnsure compliance to cGMP at all timesQualificationsDegree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)Post-graduate studies as appropriate to augment primary Degree3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.2-3 years experience in validation environmentProject 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 regulationsAble to execute projects to plan.Good knowledge of quality management systems.Effective facilitator.Good communication skills at organisation, team and individual levels.Understands KPI's for the site.Personal CharacteristicsNatural 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.