Computer System Validation
Pubblicato il 16-10-2026 - S.T.B. VALITECH in Roma
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. This position is ideal for candidates with 3-5 years of experience that works independently with clients and ensures full compliance with GAMP 5, Annex 11, and 21 CFR Part 11. 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. * Proficiency in Microsoft Office. * Availability to travel nationwide based on project r