CQV Engineer

Summary:
The CQV Engineer will be responsible for executing commissioning, qualification, and validation testing activities in a GMP pharmaceutical manufacturing environment. This role is strictly focused on test execution, protocol execution, and documentation support for process and equipment validation. The engineer will support validation of autoclaves, parts washers, and isolator filling systems, as well as associated utilities and processes. This is a hands-on, field-based role focused on following approved protocols, generating documentation, and supporting deviation resolution.
Roles & Responsibilities:

• Execute IQ, OQ, and PQ protocols for pharmaceutical manufacturing equipment and processes.
• Perform hands-on test execution for:
• Autoclaves
• Parts washers
• Isolator filling systems
• Support process validation and equipment validation activities in a GMP environment.
• Execute cycle development and cycle qualification studies for sterilization and cleaning processes.
• Document all test results in accordance with GMP and site procedures.
• Identify, document, and support the resolution of deviations, discrepancies, and test exceptions. Required Experience:
• Experience in CQV, validation, or commissioning in the pharmaceutical industry.
• Hands-on experience executing IQ/OQ/PQ protocols in a GMP environment.
• Experience with one or more of the following systems:
• Autoclaves
• Parts washers
• Isolator filling lines
• Experience with cycle development and cycle validation is strongly preferred.
• Strong understanding of GMP, FDA, and regulatory requirements.
• Strong documentation and technical writing skills.