Junior Computer System Validation

7 ore fa

Reggio Emilia, Italia Meet Life Sciences A tempo pieno

Junior Computer System Validation (CSV) Engineer Location: Verona, Italy Full TimeAbout the Role We 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 Responsibilities Support 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 Specifications IQ / OQ / PQ protocols Participate insystem testing , defect tracking, and traceability matrices Supportdata integrity and compliance assessments Work closely withQuality, IT, Automation, Engineering, and Laboratory teams Assist withaudit and inspection readinessactivities Maintain documentation in line withGMP, GAMP 5, EU Annex 11, and 21 CFR Part 11Essential Requirements Degree in Biomedical Science(or a very closely related life science discipline) Strong interest and passion for computer science, IT systems, or technology Demonstrable interest inhow software and systems are used in regulated environments Good written documentation and communication skills Strong attention to detail and analytical thinking Willingness to learn, ask questions, and work in a structured, regulated settingDesirable (Not Essential) Exposure tocoding, scripting, data analysis, or computer science modules(academic or self-taught) Internship, placement, or graduate experience inpharma, biotech, laboratories, or medtech Awareness ofGxP, GMP, GAMP 5, EU Annex 11, or FDA 21 CFR Part 11 Familiarity with systems such asLIMS, QMS, MES, or ERP Interest indata integrity, automation, or digital transformation in life sciencesWhat We Offer Structuredtraining and mentoringin CSV and regulated systems Hands-on experience withreal GMP validation projects A clearcareer pathwayinto CSV Engineer / Validation Engineer roles Exposure toaudits, inspections, and regulatory expectations Competitive entry-level salary / rate A supportive team environment that encourages learning and developmentThis Role Is Ideal For: Biomedical Science graduates who are passionate abouttechnology and computer systems Candidates looking to combinelife sciences with computer science Graduates seeking a long-term career inCSV, validation, or quality systems

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