CQV Engineer (Commissioning, Qualification & Validation)
CQV Engineer (Commissioning, Qualification & Validation)
Salary: $80,000 - $100,000
Experience: 5-10 years
We are seeking an experienced CQV Engineer to join our team. The ideal candidate will have a proven track record of IOQ (Installation/Operational Qualification) generation and execution for key pharmaceutical equipment, including isolators, filling lines, depyrogenation tunnels, vial washers, stopper machines, and cappers.
Key Responsibilities:
- Develop and execute IOQ protocols for critical filling and packaging equipment.
- Perform commissioning and qualification activities for isolators, filling lines, vial washers, and related equipment.
- Lead validation projects ensuring compliance with regulatory standards (GMP, FDA, etc.).
- Collaborate with cross-functional teams (engineering, quality, operations) to ensure timely project execution.
- Troubleshoot and optimize equipment performance.
Requirements:
- Bachelor’s degree in engineering or related field.
- 5-10 years of experience in CQV within the pharmaceutical or biotech industry.
- Strong understanding of GMP regulations and validation standards.
- Ability to hit the ground running and work independently.
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