CQV Engineer Midwest

Position Summary :

We are seeking a highly skilled CQV (Commissioning, Qualification, and Validation) Engineer for a contract position with a strong focus on DeltaV Automation . The successful candidate will be responsible for the qualification and validation of automated systems in a regulated biopharmaceutical manufacturing environment. This role involves executing CQV protocols, ensuring compliance with industry standards, and collaborating with cross-functional teams to optimize automation processes.

Key Responsibilities :

• Develop, review, and execute CQV protocols (IQ, OQ, PQ) for DeltaV automation systems.
• Ensure compliance with cGMP, GAMP5, 21 CFR Part 11, FDA, and other regulatory requirements .
• Conduct risk assessments, gap analyses, and validation impact assessments for automation systems.
• Collaborate with cross-functional teams including Quality, Engineering, and Manufacturing to ensure successful commissioning and qualification.
• Support troubleshooting, change management, and deviation resolution related to DeltaV automation.
• Maintain thorough documentation of validation activities and provide support for audits and regulatory inspections.
• Participate in system lifecycle management, continuous improvement initiatives , and validation strategy enhancements.

Required Qualifications :

Preferred Qualifications :

Contract Details :

This contract role offers an exciting opportunity to work with cutting-edge automation technologies in a regulated environment, contributing to the efficiency and compliance of pharmaceutical manufacturing operations.