PpFortil is an engineering consulting group active across Europe since 2009. We support our partners in the success of their technical projects in various sectors such as Industry, IT, and Care. /ppToday, we are more than 2,700 employees across 11 countries. Working with us means being part of an ambitious team in a multicultural and international environment! Our ambition is to help build a more responsible, supportive and inclusive world for our employees and clients. /ph3About the Role /h3pWe are currently seeking a bSenior Computer System Validation (CSV) Consultant /b to join our growing team in bCampania /b. /ph3Responsibilities /h3ulliValidation of computerized systems in the Life Science sector (e.g. laboratory instrumentation control systems, automation systems and quality systems - ERP, LIMS, DMS - according to the GxP reference regulations and GAMP Guidelines; /liliSupport in the management of remediation or requalification projects for the adaptation of computerized systems to the FDA 21 CFR part 11/EU Annex 11 regulations and to the Data Integrity regulations and guidelines; /liliPeriodic review of computerized systems and user audit trails; /liliDrafting of validation documents: Validation Plans, URS, Traceability Matrices; /liliDrafting and execution in the field of test protocols: IQ/OQ/PQ; /liliDrafting of Risk Assessments; /liliDrafting of computerized system administration procedures; /li /ulh3About You /h3ulliBachelor\'s or Master\'s degree in technical-engineering or similar subjects (Chemical Engineering, Chemistry, Industrial Chemistry, Mechanical Engineering, CTF, Pharmacy, Biology); /lili5+ years of experience on CSV projects in the Life Science field; /liliSkilled in mapping data flows and performing gap analyses to identify compliance and process improvement opportunities; /liliGood knowledge of the reference regulations and guidelines. In particular, knowledge of GMP, CFR 21 Part 11 Regulations, EU/GMP Annex 11, ISPE GAMP5 guidelines, data integrity regulations and guidelines (e.g. MHRA, WHO, EMA, FDA) and ICH guidelines, in particular ICH Q9, is required; /liliGood knowledge of the English language, both written and spoken; /liliExcellent knowledge of the Office package; /li /ulh3Next Steps /h3ulliSomeone from the Talent Acquisition department will contact you to schedule an initial HR interview. /liliIf successful, a second interview will be conducted to validate your technical knowledge. /liliIn case of a positive outcome from the technical interview, there will be a last qualification meeting with the Client. /liliIf the final outcome is positive, we will discuss our proposal with you. Alternatively, if the outcome is negative, we will share our sincere feedback! /li /ulh3Why Fortil? /h3pAlthough we currently find ourselves in a significant phase of expansion, the high standards of our projects and recruitments remain as demanding as ever. Quality will always take precedence over quantity, as we prefer excellence to ease! /ppWe hope to become the largest independent engineering group in Europe, working to serve future generations. To do so, our operational model is based on four fundamental aspects: /pulliProfitable performance /liliExpert engineers /liliEfficient organisation /liliSocial responsibility /li /ulpApply and join us to become part of a model that is out of the ordinary! /p /p #J-18808-Ljbffr