OverviewAvertim 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 RoleAs 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 DeliveryLead 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 ReportsEnsure systems comply with regulatory requirements (FDA 21 CFR Part 11, EMA Annex 11) and industry best practicesSupport audits and inspections by providing validation evidence and expert guidanceClient EngagementAdvise clients on CSV strategy, lifecycle management, and data integrity principlesCollaborate with Quality, IT, and Business teams to align validation efforts with operational needsIdentify gaps and propose remediation plans to strengthen compliance postureWork alongside QA professionals, IT specialists, and business stakeholders to deliver robust validation packagesContribute to knowledge sharing and continuous improvement of validation methodologiesParticipate in cross-functional initiatives related to digital transformation and quality systemsYour ProfileMaster’s degree in Life Sciences, Bioengineering, Engineering, or a related field1–5 years of experience in CSV, QA, or IT compliance within the Life Sciences industryFluent in English and DutchStrong understanding of GxP regulations, data integrity, and validation principlesFamiliarity with computerized systems used in pharma/biotech environmentsExperience with project documentation and validation lifecycle activitiesDetail-oriented, proactive, and passionate about quality and complianceWhy Join Avertim?Make a meaningful impact in a company where people and ideas matterJoin a dynamic, ambitious, and fast-growing team in the heart of EuropeBe part of an international network of cross-industry expertsBenefit from tailored learning opportunities, a clear career path, and a competitive compensation package
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