17 ott - Italia
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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