Junior Computer System Validation
3 giorni fa
Junior Computer System Validation (CSV) EngineerLocation: Verona, ItalyFull TimeAbout the RoleWe are seeking a Junior / Entry-Level Computer System Validation (CSV) Engineer with a Biomedical Science (or closely related life science) degree and a genuine passion for computer science, systems, and technology.This role is ideal for someone who understands biology, laboratories, and regulated environments, but is equally enthusiastic about computer systems, data integrity, and how technology supports patient safety and product quality.You will be trained and supported to build a career in CSV and GxP compliance, working on real validation projects within a regulated pharmaceutical or biotech environment.Key ResponsibilitiesSupport validation activities for GxP-regulated computerised systems (e.G. LIMS, QMS, MES, laboratory and equipment software)Assist in the preparation, execution, and review of CSV documentation, including:Risk Assessments (GAMP 5)URS / Functional SpecificationsIQ / OQ / PQ protocolsParticipate in system testing, defect tracking, and traceability matricesSupport data integrity and compliance assessmentsWork closely with Quality, IT, Automation, Engineering, and Laboratory teamsAssist with audit and inspection readiness activitiesMaintain documentation in line with GMP, GAMP 5, EU Annex 11, and 21 CFR Part 11Essential RequirementsDegree in Biomedical Science (or a very closely related life science discipline)Strong interest and passion for computer science, IT systems, or technologyDemonstrable interest in how 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 settingDesirable (Not Essential)Exposure to coding, scripting, data analysis, or computer science modules (academic or self-taught)Internship, placement, or graduate experience in pharma, biotech, laboratories, or medtechAwareness of GxP, GMP, GAMP 5, EU Annex 11, or FDA 21 CFR Part 11Familiarity with systems such as LIMS, QMS, MES, or ERPInterest in data integrity, automation, or digital transformation in life sciencesWhat We OfferStructured training and mentoring in CSV and regulated systemsHands-on experience with real GMP validation projectsA clear career pathway into CSV Engineer / Validation Engineer rolesExposure to audits, inspections, and regulatory expectationsCompetitive entry-level salary / rateA supportive team environment that encourages learning and developmentThis Role Is Ideal For:Biomedical Science graduates who are passionate about technology and computer systemsCandidates looking to combine life sciences with computer scienceGraduates seeking a long-term career in CSV, validation, or quality systems
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