CQV Project Engineer III

CRB Group • Raleigh, NC

66d

About The Position

CRB is seeking a highly motivated and self-driven CQV Engineer III to support the delivery and execution of Commissioning, Qualification, and Validation (CQV) services across Life Sciences projects. The ideal candidate will provide technical leadership and field execution support for equipment and utility systems from design through facility turnover. This role involves guiding internal and external CQV resources, coordinating with multi-disciplinary project teams, and ensuring compliance with client and global regulatory requirements. The CQV Engineer II will develop and implement commissioning strategies, lead verification activities, and manage deliverables in alignment with project timelines and quality standards. The position requires excellent organization, communication, and leadership skills, as well as the ability to work collaboratively across engineering, QA, and construction teams in a dynamic project environment.

Requirements

• Master's Degree in Engineering, Life Sciences, or related field with minimum 5 years of CQV experience, OR Bachelor's Degree in Engineering, Architecture, or Construction Management with minimum 5+ years of CQV experience in the Life Sciences industry
• Proven experience with commissioning and qualifications of life sciences equipment and utility systems (e.g., process equipment, clean utilities, HVAC, WFI, CIP/SIP, nitrogen, compressed air, etc.)
• Working knowledge of cGMP, FDA, EU, and ISPE guidelines, including ISPE Baseline Guide 5 and Risk-Based Approach to Commissioning and Qualification
• Familiarity with URS, FAT, SAT, IQ, OQ, PQ documentation and execution
• Proficiency in risk assessment methodologies, root cause analysis, and continuous improvement tools

Nice To Haves

• Strong interpersonal, communication, and presentation skills
• Demonstrated leadership in coordinating cross-functional CQV efforts
• Excellent technical writing and document review capability
• Flexible and willing to travel as needed (50% or more)

Responsibilities

• Define and document client requirements and develop project-specific CQV plans
• Review and approve commissioning and qualification strategies for equipment and utilities
• Provide input on operability, maintainability, and reliability considerations during design
• Lead or support execution of commissioning, qualification, and validation activities
• Witness and verify FAT/SAT, test protocols, and qualification execution
• Provide independent verification and quality oversight of CQV deliverables
• Act as the primary interface between CQV, engineering, and construction teams
• Develop and manage CQV schedules, ensuring alignment with project milestones
• Support risk assessments and ensure compliance with regulatory expectations
• Mentor and train junior engineers and project team members on CQV best practices
• Track, report, and communicate CQV progress and issues to project and regional leadership
• Support lessons learned and continuous improvement initiatives within the CQV organization

What This Job Offers

• Career Level: Mid Level
• Industry: Credit Intermediation and Related Activities
• Education Level: Master's degree
• Number of Employees: 1,001-5,000 employees