IT Computer System Validation Engineer

Overview We are seeking an IT Computer System Validation Engineer to support the validation of software systems. This role is crucial for ensuring compliance with global regulatory requirements in a dynamic environment. Responsibilities Support the planning, coordination, and execution of validation activities for software systems. Development of validation documentation, including requirements, risk assessments, IQ/OQ/PQ protocols, traceability matrices, and validation reports. Collaborate with cross-functional teams to ensure validation activities align with compliance needs. Coordinate with Quality Lead to ensure adherence to EU GMP Annex 11, FDA requirements, and relevant ISO standards. Interact with colleagues and documentation in the Italian language. Act as the point of contact for validation-related queries. Qualifications Proven experience in software validation engineering. Strong knowledge of EU GMP, FDA 21 CFR Part 11, and ISO standards. Ability to develop comprehensive validation documentation. Fluency in Italian and English, both written and spoken. Strong communication and collaboration skills. Nice to Have Experience with validation in the pharmaceutical or biomedical industries. Familiarity with risk management techniques. Other Details This position is onsite in Italy, with two locations available: Medolla and Grosotto. The role is set to start immediately. Job Details Seniority level: Entry level Employment type: Full-time Job function: Information Technology Industries: IT Services and IT Consulting J-18808-Ljbffr

Location: Medolla, Emilia-Romagna, IT

Posted Date: 10/9/2025