OverviewCAI is a professional services company established in 1996 that serves Life Sciences and Mission Critical industries with optimized operational readiness and performance. This description reflects a Computer Systems Validation (CSV) Engineer role focused on GxP validation in regulated environments.Key ResponsibilitiesThe CSV Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.Position RequirementsBS in a Computer Science or Engineering field or equivalent experience2-7 Years’ Experience With Computer Systems Validation2 years’ experience working in a GMP environmentExperience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desiredExperience in biotech and pharma is preferred over medical deviceExperience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.Other Requirements: Excellent oral and written communication skills in English/Fluent in EnglishAble To Travel Domestically And Internationally As RequiredLa selezione rispetta il principio delle pari opportunità (l. 903/77)Seniority levelNot ApplicableEmployment typeFull-timeJob functionEngineering and Information TechnologyPharmaceutical ManufacturingLocation: Metropolitan City of Bologna, Emilia-Romagna, Italy
#J-18808-Ljbffr