Computer System Validation Engineer

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8iyvpb

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8iyvpb