Award-Winning Medical Device Organization Seeks Process Validation Expert
We are currently recruiting for a highly skilled Process Validation Specialist to join our team at our Limerick-based facility. This is an exciting opportunity to work with a leading multinational company that prides itself on excellence.
Duties:
1. Validate new manufacturing processes, equipment introductions, and process changes in accordance with industry standards and regulatory requirements.
2. Perform process validation (OQ & PQ) by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs), and other relevant regulations.
3. Utilize six sigma statistical analysis and experimental design tools to characterize processes and support process validation activities.
4. Develop, execute, and review all validation documents.
5. Define process validation requirements in alignment with approved SOPs.
6. Execute test plans according to approved procedures, tabulate test results, and organize data packages.
7. Analyze data, prepare reports, and make recommendations for improvements.
8. Investigate and troubleshoot problems, determining solutions.
9. Coordinate and execute validation change control and preparation of protocols and reports.
10. Participate in cross-functional project teams with Development, Manufacturing, Engineering, Quality, and other groups.
11. Presents summaries of validation testing for regulatory submissions.
12. Independently applies validation principles to work assignments, reviews and approves documents, and resolves problems.
13. Coordinates assigned projects and represents department on project teams.
14. Resolves validation issues of moderate scope with limited direct supervision.
Requirements:
* Bachelor's degree in a relevant engineering or science discipline, with 5+ years of relevant experience.
* Extensive understanding and application of validation principles, concepts, practices, and standards particularly in relation to Process Validation.
* Six Sigma Black Belt certification is preferred.
* Experience in Statistical analysis & experimental design is essential.