Our client, a leading company in Sligo, is recruiting for a Validation Engineer.
- Liaise with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), Factory Acceptance Trials (FAT’s) and any other associated validation issues.
- Lead validation aspects of Facility, Utility, Equipment qualifications
- Conduct Test Method Validation, Gauge R&R
- Lead software validation and 21CFR Part 11 assessments
- Assist in the development of the existing Validation Program to ensure continued compliance to the necessary regulations.
- Collate and Report on relevant Validation data/matrices.
- Ensure prompt attention to the Quality Engineering Manager and Quality Manager on areas of non-compliance.
- Ensure all Validation and Calibration documentation meets the requirements of Quality Records Procedures
- Bachelor’s degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience
- At least 2 years work experience in Quality or related field experience; Less experience may be appropriate with advanced degree.
- Demonstrates understanding of how their function supports the business.
- Demonstrates technical and business competencies that drive results and continuous improvement
For a confidential discussion and more information on the role, please contact Colin Byrne: