Job Title: Validation Engineer
Key Responsibilities
1. Contribute to the planning, execution and completion of process validations and/or trial activities within a high-volume medical device injection moulding / automation environment.
2. Translate customer specifications into an effective validation master plan.
3. Organize cross-functional meetings to ensure successful validation plans and provide relevant metrics.
4. Coordinate the inspection and measurement of all validation and/or trial samples according to approved protocols and SOPs.
5. Analyse data and provide timely and accurate feedback to stakeholders throughout the validation process.
6. Assist in preparing reports and protocols as necessary.
7. Maintain compliant documentation, including GDP standards, and store paperwork in designated locations.
8. Develop and maintain best practice validation templates.
9. Properly store validation samples and maintain the validation sample area.
10. Collaborate with Metrology Engineers on MSA/Gauge R&R tasks.
11. Ensure adherence to GMP, EHS and housekeeping standards.
12. Support continuous improvement initiatives, including GMP, GDP and other quality-related activities.
13. Address customer queries related to specifications and quality issues during validation activities.
14. Pursue ongoing professional development opportunities.