Junior Computer System Validation

3 giorni fa


Bolzano, Italia Meet Life Sciences A tempo pieno

Junior Computer System Validation (CSV) Engineer?? Location: Verona, Italy?? Full Time?? About the RoleWe are seeking aJunior / Entry-Level Computer System Validation (CSV) Engineerwith aBiomedical Science (or closely related life science) degreeand agenuine passion for computer science, systems, and technology.This role is ideal for someone who understandsbiology, laboratories, and regulated environments, but is equally enthusiastic aboutcomputer systems, data integrity, and how technology supports patient safety and product quality.You will be trained and supported to build a career inCSV and GxP compliance, working on real validation projects within a regulated pharmaceutical or biotech environment.?? Key ResponsibilitiesSupport validation activities forGxP-regulated computerised systems(e.g. LIMS, QMS, MES, laboratory and equipment software)Assist in the preparation, execution, and review ofCSV documentation, including:Risk Assessments (GAMP 5)URS / Functional SpecificationsIQ / OQ / PQ protocolsParticipate insystem testing, defect tracking, and traceability matricesSupportdata integrity and compliance assessmentsWork closely withQuality, IT, Automation, Engineering, and Laboratory teamsAssist withaudit and inspection readinessactivitiesMaintain documentation in line withGMP, GAMP 5, EU Annex 11, and 21 CFR Part 11?? Essential RequirementsDegree in Biomedical Science(or a very closely related life science discipline)Strong interest and passion for computer science, IT systems, or technologyDemonstrable interest inhow software and systems are used in regulated environmentsGood written documentation and communication skillsStrong attention to detail and analytical thinkingWillingness to learn, ask questions, and work in a structured, regulated setting?? Desirable (Not Essential)Exposure tocoding, scripting, data analysis, or computer science modules(academic or self-taught)Internship, placement, or graduate experience inpharma, biotech, laboratories, or medtechAwareness ofGxP, GMP, GAMP 5, EU Annex 11, or FDA 21 CFR Part 11Familiarity with systems such asLIMS, QMS, MES, or ERPInterest indata integrity, automation, or digital transformation in life sciences?? What We OfferStructuredtraining and mentoringin CSV and regulated systemsHands-on experience withreal GMP validation projectsA clearcareer pathwayinto CSV Engineer / Validation Engineer rolesExposure toaudits, inspections, and regulatory expectationsCompetitive entry-level salary / rateA supportive team environment that encourages learning and development?? This Role Is Ideal For:Biomedical Science graduates who are passionate abouttechnology and computer systemsCandidates looking to combinelife sciences with computer scienceGraduates seeking a long-term career inCSV, validation, or quality systems



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