Csv engineer
Pubblicato il 13-08-2026 - EFOR in Italia
We are seeking a motivated CSV Engineer to join our team. The ideal candidate will be responsible for ensuring that computerized systems are validated in compliance with industry regulations (Gx P, FDA 21 CFR Part 11, EU Annex 11) and internal company procedures. Responsibilities Develop, review, and execute validation documentation (URS, FS, DS, IQ, OQ, PQ, traceability matrices, validation reports, etc.) Ensure systems' compliance with applicable regulatory requirements Participate in risk assessments and define validation strategies Provide expertise and support during internal and external audits Liaise with Quality, IT, and business teams to coordinate validation activities Monitor and maintain the validated state of computer systems over their life cycle Train end‐users on relevant procedures and systems,
when required Qualifications Bachelor's or Master's degree in Life Sciences, Engineering, Computer Science, or a related field Prior experience in computer system validation, preferably in regulated industries (pharma, biotech, medical device) Strong understanding of Gx P guidelines and relevant regulations (e.g., 21 CFR Part 11, Annex 11) Experience with validation of laboratory, manufacturing, or quality systems Excellent documentation, organizational, and communication skills Ability to work on multiple projects simultaneously and as part of a team Fluency in English #J-18808-Ljbffr