Computer System Validation Engineer

Overview

As a Computer Systems Validation (CSV) Engineer at CAI, you design and execute validation protocols for GMP environments, ensuring compliant, data-grade systems. You will craft and review GxP and 21 CFR Part 11 documentation and guide resolution plans with cross-functional teams. This role connects advanced validation practices with biotech and pharma clients, delivering reliable, compliant systems at scale. You will work in a fast-moving, innovation-driven setting that values integrity and continuous improvement. Your work supports safe, efficient operations and regulatory readiness across high-stakes environments.

Responsabilità

• Develop and execute validation protocols and test scripts; identify gaps and direct resolution plans
• Write GxP computer validation documentation and 21 CFR Part 11 artifacts (assessments, plans, URS, FRS, RTM, summary reports)
• Collaborate with clients and internal teams to ensure compliance and project success

Requisiti fondamentali

• BS in Computer Science or Engineering or equivalent experience
• 2-7 years' experience with Computer systems validation
• 2 years' experience in GMP environments and aseptic process knowledge (filling line CSV and Automation experience)
• Data Integrity with GAMP and 483, compliance, consent decree experience; deep 21 CFR Part 11 experience highly desired
• Biotech/pharma experience preferred over medical device
• Experience with MES, Delta V, PI is a plus
• strong communication skills in English
• GxP validation
• 21 CFR Part 11
• GAMP
• MES
• DeltaV