Senior Validation Engineer

Senior Validation Engineer

Our medical device client in Galway requires a Senior Validation Engineer on a permanent basis. The successful candidate will work on planning and execution of all validation activities related to new product introductions.

Role/Responsibilities:
• Lead all validation activities for the company. Develop project plans for the all validation activities and report to management on the implementation of the plans.
• Review all validation processes and documentation at sub-contract manufacturing facilities.
• Generate validation documentation (MVP, IQ, OQ, PQ protocols/ reports) and assist in the execution of protocols for test method, equipment and process validations.
• Troubleshoot any process or test method validation issues associated with the validation project and provide feedback to the manufacturing and design team.
• Manage the execution of the product/process validation as per the MVP and project plan.
• Work directly with sub-contractor validation representatives to ensure their validation plans are executed to the requirements of the MVP.
• Ensure all results and data are correct and follow-up on any gaps or discrepancies.
• Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
• Provide validation assessments to Change Controls/CAPA’s, Non-Conformities and Suppliers Qualification
• Contribution to general quality system activities- Management review, CAPA.

Skills/Experience:
• Degree in Science/Engineering/technology with 5+ years experience in a similar role within the Medical Devices or related industry (Hons degree an advantage).
• Good knowledge of ISO 13485 and FDA quality requirements.
• Flexibility essential with strong project management skills.
• Strong communication & organizational skills.
• Strong understanding of validation concepts, planning methods and documentation.
• Excellent attention to detail and report-writing ability
• Proven ability to work on own initiative.
• Experience of statistical analysis methods and their application to validations is a distinct advantage.

If you would like further Information you can contact the recruiter directly:

Conor Cronin | Tel: +353 (0) 1 5079258