Job Description

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.

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

Location

• Preferred: North Carolina (Raleigh–Durham area or nearby) or Texas
• Open to travel (approximately 50% or more, depending on project assignment and client needs)
• Work Environment: Combination of office, client site, and vendor locations
• Reports To: Sr CQV Project Manager/Director or Regional CQV Lead

Qualifications

• Education:
  • 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
• Technical Experience:
  • 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
• Skills & Attributes:
  • 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)

Additional Information

All your information will be kept confidential according to EEO guidelines.

CRB is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Employment is contingent on background screening.

CRB does not accept unsolicited resumes from search firms or agencies. Any resume submitted to any employee of CRB without a prior written search agreement will be considered unsolicited and the property of CRB. Please, no phone calls or emails.

CRB offers a complete and competitive benefit package designed to meet individual and family needs.

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.