Validation Engineer Job Description
We are seeking a skilled Validation Engineer to support our company's growth and success in County Longford, Ireland. This role involves responsibility for all validation activities associated with new tools and product introductions.
Key Responsibilities:
1. Create and execute process validation protocols and reports for new product introductions and re-validations using scientific knowledge.
2. Develop solutions to sustain and improve the Quality Management System (QMS).
3. Maintain compliance to ISO 13485 and ISO 14001 systems standards.
4. Participate in site change control, ensuring effective identification and implementation of changes to validated processes.
5. Generate risk assessments covering cleaning, validation, and process.
6. Review and execute Factory Acceptance Testing and Site Acceptance Testing protocols.
7. Support Good Manufacturing Practice (GMP) and regulatory audits.
8. Prepare and deliver training modules as required.
9. Analyze data and make informed decisions based on conclusions reached from analysis.
10. Support continuous improvement through Lean Six Sigma methodologies.
11. Execute/develop change controls.
12. Perform root cause analysis of system failures/substandard performance to resolve machine and system issues.
13. Implement corrective action through the change management system.
14. Participate/lead cross-functional teams, including liaison with vendors on projects.