Computer System Validation
2 giorni fa
About S.T.B. ValiTech Founded in 2004, S.T.B. ValiTech is a company in continuous expansion, with over 200 employees, specializing in equipment qualification, industrial calibration, Computer System Validation (CSV), Clean & Black Utilities, and electro‑instrumental design and installation. With headquarters in Sabaudia and a newly opened office in Milan (Rho), we support major Life Sciences organizations, across Italy and abroad, with high‑quality, reliable and innovative technical services. About the Role We are seeking a CSV Engineer with proven experience to manage validation deliverables for complex computerized systems in highly regulated environments. You will work independently with clients and ensure full compliance with GAMP 5, Annex 11, and 21 CFR Part 11. Location: Sabaudia - Client Sites / Remote (when authorized) Responsibilities Lead and execute qualification activities (FAT, SAT, IQ, OQ, PQ) for standalone and networked computerized systems. Draft and review System Configuration and system lifecycle documentation. Develop Computer System Validation Plans and Validation Reports. Drive Risk Assessment activities (RA, Data Integrity, Process Mapping). Write and revise SOPs related to CSV and Data Integrity. Collaborate directly with client stakeholders (Engineering, QA, IT, Production). Review Functional Specifications (FS), Hardware Design Specifications (HDS), Software Design Specifications (SDS), and Configuration Specifications (CS) provided by suppliers or system developers. Ensure alignment between user requirements, system design, and validation deliverables. Requirements Bachelor’s or Master’s degree in Engineering or scientific fields is required. 3-5 years of hands‑on experience in Computer System Validation within pharmaceutical, biotech, or other GxP‑regulated industries. Solid knowledge of GAMP 5 and Data Integrity principles. Fluent English. Proficiency in Microsoft Office. Availability to travel nationwide based on project requirements. What We Offer Competitive compensation based on experience. Meal voucher / client’s canteen. A company car is available for client‑site travel and can be picked up from our headquarters in Sabaudia (LT). Smart working for agreed‑upon CSV tasks. Continuous professional development and long‑term career progression. Exposure to top‑tier industry clients and innovative technologies. #J-18808-Ljbffr
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