Validation Engineer II - Perm
My client a medical device company here in Galway are recriuting for a strong Validation Engineer to joing their team. This is a brand new role due to expansion;
Key Job Responsibilities:
- 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.
Key Requirements of the role:
- Level 8 degree in Science/Engineering.
- 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.
- Excellent attention to detail and report-writing ability
- Proven ability to work on own initiative.
- Highly organized with strong ability to prioritize tasks.
- General knowledge and experience of statistical analysis methods is an advantage.
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