CQV Validation Engineer for Pharma Systems

CAI; Wisconsin; On-site; USD 70,000 - 110,000; Full time

Job summary

CAI is seeking qualified professionals to support commissioning and qualification activities for pharmaceutical facilities. The role focuses on developing CQV documentation, executing field verification protocols, and delivering client-ready summary reports.

Ideal candidates hold a science/engineering degree with 2–4 years in regulated environments and familiarity with ISPE Baseline Guide 5. This position is on-site in Wisconsin and involves collaboration across multidisciplinary teams.

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, and pharmaceutical manufacturing processes.

Responsibilities

• Develop documentation for CQV activities.
• Write and execute protocols (field verification).
• Develop summary reports at client sites.
• Pharmaceutical facilities focus; utilities and equipment considerations.
• Plan and coordinate work; direct small teams in document development and execution.

Skills

Attention to detail

Written and verbal communication

Cross-functional collaboration

Education

Bachelor’s degree in science or engineering

2–4 years’ experience in commissioning and qualification in a regulated industry

Tools

ISPE Baseline Guide 5 (Second Edition)

Job description

CAI is seeking qualified professionals to support commissioning and qualification activities for pharmaceutical facilities. The role focuses on developing CQV documentation, executing field verification protocols, and delivering client-ready summary reports.

Ideal candidates hold a science/engineering degree with 2–4 years in regulated environments and familiarity with ISPE Baseline Guide 5. This position is on-site in Wisconsin and involves collaboration across multidisciplinary teams.