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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