CQV Engineer

Experience: 3-4 years in pharma CQV

1. Commissioning Activities:

2. Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc.

3. Participate and coordination with engineering & OEMS for FAT/SAT.

4. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM.

5. Qualification and Validation:

6. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment.

7. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO).

8. Documentation:

9. Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle.

10. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution.
11. Provide technical input during project planning and scheduling of CQV activities.
12. Track and report progress of CQV milestones, and support.
13. Good knowledge in project management and excellent communication as well as writing skills