CQV Engineer

Job Summary

Seeking a highly motivated full-time CQV Engineer, the successful candidate will lead and execute Commissioning, Qualification, and Validation (CQV) activities for critical process equipment and clean utility networks within a regulated cGMP manufacturing facility.

Key responsibilities

• Author, review, and execute CQV lifecycle documentation, including User Requirement Specifications and validation protocols
• Lead field execution of validation protocols on process systems and clean utilities
• Manage technical deviations during qualification phases and collaborate with Quality Assurance on corrective actions

Required qualifications

• Bachelor of Science (BS) degree in Chemical Engineering, Mechanical Engineering, Bioengineering, Biology, or a related field
• 3 to 10 years of direct CQV/Validation engineering experience in a cGMP environment
• Proven expertise in commissioning and qualifying clean utilities or automated process equipment
• Strong working knowledge of data integrity principles and validation methodologies
• Exceptional technical writing capabilities and ability to communicate complex technical issues clearly