H3Overview /h3pWe are seeking an bIT Computer System Validation Engineer /b to support the validation of software systems. This role is crucial for ensuring compliance with global regulatory requirements in a dynamic environment. /ph3Responsibilities /h3ulliSupport the planning, coordination, and execution of validation activities for software systems. /liliDevelopment of validation documentation, including requirements, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation reports. /liliCollaborate with cross-functional teams to ensure validation activities align with compliance needs. /liliCoordinate with Quality Lead to ensure adherence to EU GMP Annex 11, FDA requirements, and relevant ISO standards. /liliInteract with colleagues and documentation in the Italian language. /liliAct as the point of contact for validation-related queries. /li /ulh3Qualifications /h3ulliProven experience in software validation engineering. /liliStrong knowledge of EU GMP, FDA 21 CFR Part 11, and ISO standards. /liliAbility to develop comprehensive validation documentation. /liliFluency in Italian and English, both written and spoken. /liliStrong communication and collaboration skills. /li /ulh3Nice to Have /h3ulliExperience with validation in the pharmaceutical or biomedical industries. /liliFamiliarity with risk management techniques. /li /ulh3Other Details /h3ulliThis position is onsite in Italy, with two locations available: Medolla and Grosotto. The role is set to start immediately. /li /ulh3Job Details /h3ulliSeniority level: Entry level /liliEmployment type: Full-time /liliJob function: Information Technology /liliIndustries: IT Services and IT Consulting /li /ul #J-18808-Ljbffr