Pharma CQV Validation Engineer

CAI; Cleveland (OH); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Comprehensive Health Insurance

24 days of Paid Time Off

Company paid Life Insurance

Company paid Long Term Disability

Job summary

CAI is seeking a CQV-focused engineer to develop documentation for commissioning and qualification activities at client sites in the pharmaceutical sector. You will write and execute field verification protocols, create client-ready summary reports, and plan cross-functional work streams.

The role requires coordinating small teams, ensuring compliance with ISPE Baseline Guide 5 guidance, and supporting utilities, equipment start-ups, and validation activities across GMP facilities.

Qualifications

• Bachelor’s degree in a science or engineering field (or equivalent experience).
• 2–4 years’ experience in commissioning and qualification in a regulated industry
• Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus
• Preferred experience in: Facilities and equipment startup
• Walk-downs and troubleshooting
• Utilities (WFI, RO, HVAC)
• Upstream/downstream processing
• Purification, recovery
• Building automation
• Pharmaceutical manufacturing processes

Responsibilities

• Develop documentation for CQV activities
• Write and execute protocols (field verification)
• Develop summary reports at client sites
• Plan and coordinate work
• Direct small teams in document development and/or execution

Skills

Regulated industry experience

Commissioning & qualification

ISPE Baseline Guide 5

Education

Bachelor’s degree in science or engineering

Job description

CAI is seeking a CQV-focused engineer to develop documentation for commissioning and qualification activities at client sites in the pharmaceutical sector. You will write and execute field verification protocols, create client-ready summary reports, and plan cross-functional work streams.

The role requires coordinating small teams, ensuring compliance with ISPE Baseline Guide 5 guidance, and supporting utilities, equipment start-ups, and validation activities across GMP facilities.