CSV Engineer

Summary : A CSV Engineer is required for a biopharmaceutical company in Waterford. The incumbent will ensure the ongoing validation compliance of computerised equipment and systems onsite. Responsibilities : Integrally involved in the validation of all new computerised equipment, and control systems onsite. Generates validation documentation (protocols / reports) and helps 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 Sanofi 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 & Experience : Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical / Mech / Elec). 3-5 years experience working in a Healthcare manufacturing environment ideally part of which would be in the pharmaceutical sector and 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. Good knowledge of quality management systems.