Our client, a medical device company in Galway are currently looking to recruit a Validation Engineer for their site.
? Generate validation documentation (URS, IQ, OQ, PQ and process characterisation studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
? Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team.
? Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
? Ensure validation documents are up-to-date (primarily project MVPs and key inputs).
? Manage the execution of the product/process validation as per the MVP and project plan.
? Work directly with customer validation representatives to define inputs and requirements to the MVP.
? Ensure all results and data are correct and follow-up on any gaps or discrepancies.
? Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment.
? Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
? Maintain validation procedures and templates up to date, focusing on continuous improvement.
? Degree in Science/Engineering with 3+ years? experience in a similar role within the Medical Devices or related Healthcare industry.
? Strong knowledge of ISO and FDA quality requirements.
? Good understanding of validation concepts and documentation.
? Strong communication skills, including ability to advise and influence.
? Proven ability to work on own initiative.
? Highly organized with strong ability to prioritize tasks.
? A general knowledge and experience of statistical analysis methods is an advantage.