Job Description
A Validation Engineer is required by CareerWise Recruitment for our Co Cork based med device client.
Role of this position
1. Own and support validation activities in a Medical Device regulated environment.
2. Responsible for all Process Validation Executions.
3. Responsible for all Software Validation Executions.
4. Resolution of Problems encountered during validation.
5. Ensure Consistency in validation/qualification approach across systems and projects.
6. Provide guidance and direction in the preparation and execution of validation activities.
7. Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
8. Maintain Validation system including conducting Periodic Reviews.
9. Participate in change control processes for manufacturing process and facility modifications.
JOB REQUIREMENTS
10. QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
11. Minimum of 2 years Quality Assurance / Regulatory affairs experience.
12. Experience in completing Process Validation's as per CDRH Guidance
13. Experience in using Gamp 4 or Gamp 5 Software V and V Techniques .
14. Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
15. Ability to write standard operating procedures, training documents, and regulatory responses.
16. Experience in statistical Analysis / DOE and DMAIC methods.