Validation Engineer – Galway
A Medical Device multinational based in Galway are seeking a Validation Engineer with experience working within a highly regulated environment specifically Medical Devices to join their expanding team.
- Generate validation documentation and assist in the execution of protocols.
- Troubleshoot validation issues associated with the validation project and provide feedback.
- Ensure consistency on validation/qualification approach across systems and projects.
- Ensure validation documents are up-to-date.
- 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.
- Ensure all results and data are correct and follow-up on any gaps.
- Liaise with the Engineering function to ensure that equipment validation requirements are maintained.
- Provide guidance and direction in the preparation and execution of validation activities.
- Maintain validation procedures and templates up to date, focusing on continuous improvement.
- BSc. in Science/Engineering.
- 3+ years’ experience in a similar role within the Medical Devices.
- Strong knowledge of ISO and FDA quality requirements.
- Good understanding of validation concepts and documentation.
- Excellent attention to detail and report-writing ability.
- Strong ability to prioritize tasks.
- General knowledge of statistical analysis methods advantageous.
- Some travel may be required.
- Must be authorised to work in Ireland.
Please contact Mary-Ann Keena to learn more
+353 (0) 83 0220666