Process Validation Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

1. Ensure validation activities completed comply with US and EU relations, GBSC procedures and EHS requirements.
2. Review and approve documents prepared by project teams, other departments and contractor organizations (e.g. protocols, reports, change controls)
3. Assist in development of validation strategy and validation plan for equipment and process validations.
4. Assist in the development of sampling plans, test plans and data analysis related to process validation.
5. Assist in resolution of deviations/ exceptions during qualification activities
6. Assist with change control activities in accordance with site procedures.
7. Prepare periodic validation review documentation for approval by the business units.
8. Maintain site validation registry.
9. Attend identified training, required to fulfil the role
10. Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with Process Changes, Product Transfers and/or New Product Introductions.
11. Participate in cross-functional teams as required.

Education & Experience

• In depth knowledge of 21 CFR 820, 21 CFR 11, ISO 13485 and European regulations associated with the medical device industry