Junior Computer System Validation

Overview Company Description Con oltre 900 laboratori, circa 63.000 dipendenti, oltre 200.000 metodi analitici, una presenza diffusa in 62 paesi e un fatturato annuo di 6.7 BIL EUR, Eurofins è un gruppo internazionale leader nei servizi analitici conto terzi nei settori Farmaceutico, Alimentare, Ambientale e Consumer Products. Eurofins nell’ottica di potenziare la sua divisione BioPharma, al fine di fornire valore a clienti di tutto il mondo, è alla continua ricerca di persone fortemente motivate e orientate al raggiungimento dei risultati che vogliano entrare a far parte di una realtà solida e dinamica. Job Description Eurofins BioPharma Product Testing BPT) is looking for a Junior Computer System Validation based in Vimodrone (MI) , that will collaborate with the European CSV Coordinator to assure the GMP compliance requested for all the computerized systems in use in the Eurofins European Biopharma Product Testing. The role will report to the EBPT CSV Coordinator and Quality / Compliance Director. Responsibilities Execute Computerized Systems validation and Infrastructure qualification activities. Collaborate on the evaluation of changes to computerized systems / infrastructure components from a regulation and data integrity perspective. Collaborate on the investigation and resolution of compliance issues (Deviation and CAPA). Verify if a computerized system (infrastructure included) is designed according to applicable regulatory and data integrity requirements by reviewing User Requirements and Software / Infrastructure Specifications. Contribute to delivering Computerized Systems validation and Infrastructure Qualification documents. Support maintaining the system / infrastructure in the validated / qualified status along with its lifecycle and keeping validation / qualification documentation up to date. Manage the periodic review process for relevant computerized systems / infrastructure components. Maintain the EUBPT computerized systems Inventory List. Collaborate with internal / supplier audit teams during audits in the GAMP area. Qualifications Professional Experience Experiences in Quality area with knowledge on: computerized systems related quality processes (e.g. Change Control, Deviation, CAPA); Computer System Compliance and Validation Life Cycle; CFR Part 11 and EU GMP Annex 11 principles; Experiences in IT areas with knowledge on computerized systems typically used in Pharma Laboratory environments or equivalent working areas. Professional knowledge Computerized systems used in analytical laboratories (e.g. CDS, LIS, LIMS); Infrastructure components (e.g. Router, Access Point, Firewall); GAMP guidance; GMP Regulation for computer system (EU GMP-volume 4 annex 11; CFR21 part 11) and pharma industry (EU GMP volume 4, CFR21 part 210, 211); Data governance and data Integrity principles. Managerial Skills Problem solving; Team working / collaboration; Precision and control; Flexibility: planning and organizing. Benefits Orario Flessibile Ticket Restaurant 8€ / giorno Company Welfare To apply it’s necessary to send a detailed CV and cover letter, specifying the authorization to process personal data. CVs without these requirements will not be taken into consideration. The hiring will be with a fixed contract (with permanent hiring purpose). To learn more about Eurofins, please explore our website J-18808-Ljbffr

Location: Venezia, Veneto, IT

Posted Date: 9/8/2025