CAI
Validation Engineer
About this role
CAI seeks a Validation Engineer to lead commissioning and qualification activities for pharmaceutical and utility facilities. You'll develop CQV documentation, execute field verification protocols, and manage small teams while ensuring mission-critical systems meet regulated industry standards.
What you'll do
- Develop and maintain comprehensive documentation for commissioning, qualification, and validation (CQV) activities
- Write and execute field verification protocols at client pharmaceutical and utility facilities
- Create summary reports documenting validation results and compliance findings
- Plan and coordinate validation projects across equipment, utilities, and facility systems
- Direct and mentor small teams in document development and protocol execution
- Troubleshoot equipment and systems during facility and equipment startup phases
What they're looking for
- Commissioning and qualification protocols
- Technical documentation and report writing
- ISPE Baseline Guide 5 knowledge
- Pharmaceutical manufacturing processes
- Utilities systems (WFI, RO, HVAC, building automation)
- Project planning and coordination
- Team leadership and mentoring
- Regulatory compliance and quality standards
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CAI
CAI provides commissioning, qualification, and validation services for pharmaceutical and life sciences facilities in regulated environments. The company is hiring Validation Engineers to lead CQV activities, develop technical documentation, execute verification protocols at client sites, and manage teams to ensure regulatory compliance and operational readiness.
View all jobs at CAILikely interview questions
- Describe your experience with commissioning and qualification in a regulated industry—what systems have you validated?
- How do you approach developing CQV documentation to ensure it meets regulatory requirements?