Computer System Validation (Csv) Engineer
Pubblicato il 14-10-2026 - S.T.B. VALITECH in Latina
h3About S.T.B. ValiTech /h3 pFounded in ****, 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.
/p h3About the Role /h3 pWe 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.
/p h3Responsibilities /h3 ul liLead and execute qualification activities (FAT, SAT, IQ, OQ, PQ) for standalone and networked computerized systems.
/li liDraft and review System Configuration and system lifecycle documentation.
/li liDevelop Computer System Validation Plans and Validation Reports.
/li liDrive Risk Assessment activities (RA, Data Integrity, Process Mapping).
/li liWrite and revise SOPs related to CSV and Data Integrity.
/li liCollaborate directly with client stakeholders (Engineering, QA, IT, Production).
/li liReview Functional Specifications (FS), Hardware Design Specifications (HDS),
Software Design Specifications (SDS), and Configuration Specifications (CS) provided by suppliers or system developers.
/li liEnsure alignment between user requirements, system design, and validation deliverables.
/li /ul h3Requirements /h3 ul liBachelor's or Master's degree in Engineering or scientific fields is required.
/li li3-5 years of hands?on experience in Computer System Validation within pharmaceutical, biotech, or other GxP?regulated industries.
/li liSolid knowledge of GAMP 5 and Data Integrity principles.
/li liProficiency in Microsoft Office.
/li liAvailability to travel nationwide based on project requirements.
/li /ul h3Language Requirements: /h3 ul liFluent Italian (mandatory) /li liGood English knowledge (written and spoken) /li /ul pNote: Applications from candidates who do not speak Italian cannot be considered.
/p h3What We Offer /h3 ul liCompetitive compensation based on experience.
/li liMeal voucher / client's canteen.
/li liA company car is available for client?site travel and can be picked up from our headquarters in Sabaudia (LT).
/li liSmart working authorized by the company for CSV activities suitable for remote execution.
/li liContinuous professional development and long-term career progression.
/li liExposure to top-tier industry clients and innovative technologies.
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