Full-Time

Commissioning Qualification Validation Engineer 3

CRB

CRB

Life sciences design and construction

No salary listed

Raleigh, NC, USA

Hybrid

Hybrid role; travel 50% or more required.

Bachelor's, Master's

Category
Biology & Biotech (2)
,
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
  • 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.)
  • Technical Experience: Working knowledge of cGMP, FDA, EU, and ISPE guidelines, including ISPE Baseline Guide 5 and Risk-Based Approach to Commissioning and Qualification
  • Technical Experience: Familiarity with URS, FAT, SAT, IQ, OQ, PQ documentation and execution
  • Technical Experience: Proficiency in risk assessment methodologies, root cause analysis, and continuous improvement tools
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
Desired Qualifications
  • 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)

CRB is an engineering, architecture, construction, and consulting firm serving life-sciences organizations. The company plans, designs, builds, and improves laboratories, manufacturing facilities, food plants, and other technically complex environments. It serves biotechnology, pharmaceutical, food and beverage, advanced technology, and research organizations. Its operating model centers on integrated project teams combining consulting, design, engineering, construction, commissioning, and operational expertise. Teams work across architecture, engineering, construction, consulting, project management, commissioning, and technical operations. Work depends on specialist expertise, clear client coordination, practical delivery, and ongoing support across projects and operating teams.

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