Role Purpose:A new vacancy has arisen for an experienced Validation Engineer to join our client's GMP pharmaceutical manufacturing site based in County Waterford.In the Validation Engineer role, you will be required to support a new projectThe Validation Engineer has a key role in ensuring the on-going validation and compliance of new equipment, systems and processes on site. The following activities will be included as part of your role.Core Duties and Responsibilities:Executing FAT/SAT/IOQ protocols including generation of protocols and reports.Designing, executing and reporting on validation studies for equipment, systems and processes.Ensuring validation studies are managed in conjunction with all required company 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 timesMaintaining validation documentation through the validation lifecycleParticipation in external regulatory inspectionsSupport Site Change Control processEducation & Qualifications Required: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.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 Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.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 regulationsAble 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 advantageUnderstands KPI's for the site.Previous Equipment knowledge for example pack lines, Autoclaves, Isolator Technology and fill lines would be an advantage.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.For information on how we process your data, please see our Prochem Privacy Policy.