CQV Engineer
Job Summary
The CQV Engineer is responsible for developing and executing validation protocols (IQ/OQ/PQ) in accordance with URS and risk assessments. This role involves coordinating cross-functional activities with engineering and quality departments to ensure project readiness. Additionally, the engineer will manage change controls and lead deviation investigations to maintain compliance.
Responsibilities
- Develop/execute IQ/OQ/PQ protocols
- Lead risk and impact assessments
- Manage change control processes
- Coordinate cross-functional project activities
- Lead deviation/variation investigations
Required Skills
- Validation (IQ/OQ/PQ)
- URS and Risk Assessment
- Clean air equipment qualification
- Sterilization cycle qualification
- Change control management
Job Details
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.
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.