Validation EngineerA leading Biotech company based in Waterford is seeking a Validation engineer to add to their team on a 12month contract. This is a Hybrid role but successful applicant must be flexible to come to site when required.Our Team:In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes at Sanofi Ireland. The following activities will be included as part of your role.Main responsibilities:The following activities will be included as part of your role:· Designing, executing and reporting on PQ Performance Qualifications.· Designing, executing and reporting on validation studies for equipment, systems and processes.· Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)· Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation· Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times· Maintaining validation documentation through the validation lifecycle· Participation in external regulatory inspections· Support Site Change Control processAbout you· 3-5 years' experience working in a Healthcare manufacturing environment - ideally part of which would be in the pharmaceutical sector.· 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.· Capable of troubleshooting validation issues associated with projects, process development etc.· Competent technical knowledge of pharmaceutical plants.· Previous validation/product development experience would be highly advantageous for the role.· Knowledge of requirements for of GAMP, ISPE Baseline guides.· Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.· Full understanding of relevant quality and compliance regulations· Able to execute projects to plan.· Good knowledge of quality management systems.· Good communication skills at organisation, team and individual levels.· Ability to use MS Project and SPC packages an advantage· Understands KPI's for the site.Education: Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)For more information and a confidential chat, feel free to reach out to me on or call me on 01-482 5494
