Consultant : CSV Validation Engineer
il y a 4 jours
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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Consultant: CSV Validation Engineer
il y a 3 semaines
Antwerp, Belgique Avertim Temps pleinAbout 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...
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Consultant: CSV Validation Engineer
il y a 3 semaines
Antwerp, Belgique Avertim Temps pleinAbout 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...
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Project Validation Coordinator
il y a 2 semaines
Antwerp, Belgique Jefferson Wells Belgium Temps pleinProject Validation Coordinator Antwerp – Contracting What are your responsibilities? The Project Validation Coordinator supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation. The role ensures consolidation of validation documentation, monitoring of validation strategy, coaching on...
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Project Validation Coordinator
il y a 2 semaines
Antwerp, Belgique Jefferson Wells Belgium Temps pleinProject Validation Coordinator Antwerp – ContractingWhat are your responsibilities?The Project Validation Coordinator supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation. The role ensures consolidation of validation documentation, monitoring of validation strategy, coaching on...
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Project Validation Coordinator
il y a 2 semaines
Antwerp, Belgique Jefferson Wells Belgium Temps pleinProject Validation Coordinator Antwerp – ContractingWhat are your responsibilities?The Project Validation Coordinator supports the project lead in coordinating the project team to achieve the defined project deliverables in relation to validation. The role ensures consolidation of validation documentation, monitoring of validation strategy, coaching on...
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Project Engineer Utilities
il y a 4 semaines
Antwerp, Belgique Vulcain Engineering Group | Belgium Temps pleinVulcain Engineering Belgium is looking for a Project Engineer Utilities to join its team.As project engineer, you will manage technical or engineering projects, working with stakeholders at all levels, with direct responsibility for budgeting, personnel and project planning and making sure the project is finished on time and on budget. Not only will you work...
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Project Engineer Utilities
il y a 5 jours
Antwerp, Belgique Vulcain Engineering Group | Belgium Temps pleinVulcain Engineering Belgium is looking for a Project Engineer Utilities to join its team.As project engineer, you will manage technical or engineering projects, working with stakeholders at all levels, with direct responsibility for budgeting, personnel and project planning and making sure the project is finished on time and on budget. Not only will you work...
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Project Engineer Utilities
il y a 5 jours
Antwerp, Belgique Vulcain Engineering - Belgium Temps pleinVulcain Engineering Belgium is looking for a Project Engineer Utilities to join its team.As project engineer, you will manage technical or engineering projects, working with stakeholders at all levels, with direct responsibility for budgeting, personnel and project planning and making sure the project is finished on time and on budget. Not only will you work...
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Project Engineer Utilities
il y a 5 jours
Antwerp, Belgique Vulcain Engineering - Belgium Temps pleinVulcain Engineering Belgium is looking for a Project Engineer Utilities to join its team. As project engineer, you will manage technical or engineering projects, working with stakeholders at all levels, with direct responsibility for budgeting, personnel and project planning and making sure the project is finished on time and on budget. Not only will you...
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Linux System Engineer
il y a 4 semaines
Antwerp, Belgique Kwery Temps pleinVoor onze klant, een dynamisch en groeiend bedrijf actief in de IT- en softwareconsultancysector in Antwerpen, ben ik op zoek naar een Linux System Engineer / Open Source Consultant. Het bedrijf staat bekend om zijn innovatieve oplossingen voor enterprise-omgevingen, waarbij ze open source-technologieën combineren met cloud- en infrastructuuroplossingen om...
