Consultant : CSV Validation Engineer
il y a 13 heures
About Avertim Avertim is a uniquely positioned management consulting group that bridges the gap between strategy, technology, and operations. Founded in 2007 and headquartered on Brussels' iconic Avenue Louise, Avertim has grown into a European consultancy with over 350 consultants across Belgium, France, Germany, and the Netherlands. Our mission: to support leading Life Sciences companies in their digital transformation journey, helping them unlock the power of data, innovation, and compliance. Your Role As a CSV Consultant, you'll contribute to the validation of computerized systems in regulated Life Sciences environments. You'll ensure that digital solutions meet compliance standards and support quality, safety, and data integrity across pharma, biotech, and medtech organizations. Project Delivery Lead and execute Computer System Validation (CSV) activities for GxP-regulated systems (e.g. LIMS, MES, ERP, TrackWise, Veeva, SAP,...) Develop and maintain validation documentation: URS, Risk Assessments, Validation Plans, Test Protocols (IQ/OQ/PQ), and Reports Ensure systems comply with regulatory requirements (FDA 21 CFR Part 11, EMA Annex 11) and industry best practices Support audits and inspections by providing validation evidence and expert guidance Client Engagement Advise clients on CSV strategy, lifecycle management, and data integrity principles Collaborate with Quality, IT, and Business teams to align validation efforts with operational needs Identify gaps and propose remediation plans to strengthen compliance posture Team Collaboration Work alongside QA professionals, IT specialists, and business stakeholders to deliver robust validation packages Contribute to knowledge sharing and continuous improvement of validation methodologies Participate in cross-functional initiatives related to digital transformation and quality systems Your Profile Master's degree in Life Sciences, Bioengineering, Engineering, or a related field 1–5 years of experience in CSV, QA, or IT compliance within the Life Sciences industry Fluent in English and DutchStrong understanding of GxP regulations, data integrity, and validation principles Familiarity with computerized systems used in pharma/biotech environments Experience with project documentation and validation lifecycle activities Detail-oriented, proactive, and passionate about quality and compliance Why Join Avertim? Make a meaningful impact in a company where people and ideas matter Join a dynamic, ambitious, and fast-growing team in the heart of Europe Be part of an international network of cross-industry experts Benefit from tailored learning opportunities, a clear career path, and a competitive compensation package
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il y a 2 semaines
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il y a 13 heures
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