15 ott - Varese
Cai
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
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