Senior CQV Validation Engineer - GMP Compliance

Katalyst CRO; Harvard (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for GMP-regulated process equipment. You will execute IQ/OQ protocols, perform temperature mapping, and support SIP/CIP validation, while ensuring documentation compliance across QA, Engineering, and Operations teams.

Ideal candidates bring hands-on CQV experience, familiarity with eVal/ValGenesis and Ellab, and a willingness to support second-shift or weekend work as needed.

Qualifications

• Bachelor's degree in STEM, Biomedical Engineering, Chemical Engineering, or a related technical discipline preferred.
• Hands-on CQV/Validation engineering experience in GMP-regulated environments.
• Experience executing IQ/OQ, field verification, and validation documentation practices.
• Exposure to equipment startup, integration, and cross-functional collaboration.

Responsibilities

• Execute IQ and OQ protocols for process equipment and utility systems.
• Perform drawing walkdowns, including P&ID reviews and system verification activities.
• Conduct equipment verification during commissioning and qualification phases.
• Support MOC activities and weld verification as part of validation processes.
• Perform temperature mapping studies using data loggers and validation tools such as Ellab.
• Assist with SIP/CIP execution, cycle development, and validation activities.
• Identify, document, and investigate deviations encountered during qualification and validation activities.
• Ensure compliant documentation according to GMP and GDP requirements.
• Collaborate with Engineering, QA, Manufacturing, and Operations to support deliverables.
• Support field verification activities to meet regulatory and quality standards.
• Utilize validation lifecycle management systems such as eVal and ValGenesis.
• Participate in equipment startup and continuous improvement initiatives for validated systems.

Job description

Katalyst CRO is seeking a Senior CQV Engineer to lead commissioning, qualification, and validation activities for GMP-regulated process equipment. You will execute IQ/OQ protocols, perform temperature mapping, and support SIP/CIP validation, while ensuring documentation compliance across QA, Engineering, and Operations teams.

Ideal candidates bring hands-on CQV experience, familiarity with eVal/ValGenesis and Ellab, and a willingness to support second-shift or weekend work as needed.