Senior Validation Engineer - Contracting Opportunity
We are partnering with an innovative medical device company who is developing cutting-edge technology and gearing up for FDA approval at their manufacturing site in Galway.
To support development and manufacturing efforts, they require a Senior Validation Engineer on a 6-month contract to cover validation activities related to testing and production of this new Medical Device product.
Job Overview:
1. Develop and/or approve validation documentation, including protocols, records, and reports.
2. Perform process and test method validation activities within the project scope.
3. Execute process and test method validation activities in collaboration with Operations, Quality Assurance, and R&D teams.
4. Ensure all validation activities are completed and reported in a timely manner according to the project plan.
5. Maintain compliance with current Good Manufacturing Practices (GMPs) and 21 CFR 820 requirements in all validation aspects.
6. Communicate validation requirements to all functional groups.
7. Analyze and troubleshoot validation problems and determine solutions.
8. Present validation results and progress to management.
9. Prepare summaries of validation testing for regulatory submissions as required.
Qualifications & Experience:
10. Bachelor's degree in engineering, technology, or science with 5+ years' experience in the medical device or pharmaceutical industry.
11. Prior experience in designing and executing process and test method validations.
12. Strong analytical skills, excellent writing, and interpersonal relationship skills or relevant work experience and education combination.
13. Demonstrated knowledge of ISO 13485 and 21 CFR 820 requirements.
14. Ability to collaborate as part of a team and meet goals efficiently.
15. Demonstrated organizational, management, and communication skills.
16. Good interpersonal and communication skills essential.