Pharma Validation Engineer – CQV Specialist

CAI; Fogelsville (Lehigh County); On-site; USD 85,000 - 120,000; 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 engineer to support commissioning and qualification activities at pharmaceutical client sites. You will develop CQV documentation, write and execute field verification protocols, and produce summary reports for client sites.

We value 2–4 years of regulated-industry experience, a Bachelor’s degree in science or engineering, and familiarity with ISPE Baseline Guide 5. Your role will involve coordinating work, leading small teams, and ensuring compliance in high-stakes

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 for CQV projects.
• Direct small teams in document development and/or execution.

Education

Bachelor’s degree in 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, utilities, and pharm processes

Job description

CAI is seeking a CQV engineer to support commissioning and qualification activities at pharmaceutical client sites. You will develop CQV documentation, write and execute field verification protocols, and produce summary reports for client sites.

We value 2–4 years of regulated-industry experience, a Bachelor’s degree in science or engineering, and familiarity with ISPE Baseline Guide 5. Your role will involve coordinating work, leading small teams, and ensuring compliance in high-stakes