CQV Engineer
Summary
Develops and executes validation protocols (IQ/OQ/PQ) for clean air equipment and sterilization cycles, ensuring compliance and traceability in a manufacturing environment.
1 KEY RESPONSIBILITIES
- Develop and execute validation (IQ/OQ/PQ) / study protocols as performer or witnessed by (depending on assignment) against approved URS and risk assessments.
- Lead or support risk assessments and impact assessments where applicable.
- Initiate change control process for any modifications affecting validated state.
- Plan, manage and coordinate activities with other functions including equipment suppliers, Engineering, Manufacturing, QC, QA.
- Track the CQV deliverables and ensure adherence to schedule from project to operation readiness.
- Ensure traceability across lifecycle documents.
- Lead resolution of variation / deviation investigation in a timely and compliant manner.
2 SCOPE OF WORK
- Qualification of clean air equipment, such as VBE (ventilated balance enclosure / negative pressure hood) etc.
- Qualification of sterilization cycle (CD, PQ) of autoclave loads.
- Qualification of temperature‑controlled unit.