> Markdown version of [/jobs/ext/1942294-computer-system-validation-consultant](https://www.wearedevelopers.com/jobs/ext/1942294-computer-system-validation-consultant). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Computer System Validation consultant - **Company:** Agidens - **Location:** Belgium (Remote available) - **Experience:** Experienced - **Contract:** Permanent contract - **Skills:** Data Integrity, Supervisory Control and Data Acquisition (SCADA), Laboratory Information Management Systems, Software Engineering - **Published:** August 6, 2026 - **Apply:** https://www.adzuna.be/details/5830300435 ## About the Role * Bachelor of master in een technische of wetenschappelijke richting of gelijkwaardig aan ervaring. * Minimaal 2 jaar ervaring in Computer System Validation binnen een GMP-omgeving, bij voorkeur in de farmaceutische industrie. * Kennis van onder meer GAMP5, USA FDA 21 CFR Part 210, 211 en 11 en EudraLex Vol.4. * Kennis van data-integriteit, ALCOA+ en ISO-13485 is een grote plus * Uitstekende communicatieve vaardigheden, zowel mondeling als schriftelijk, in Nederlands en Engels. ## Description Computer system validation zorgt voor gedocumenteerd bewijs dat geautomatiseerde (computer)systemen compliant zijn en consistent presteren. Agidens biedt zijn klanten CSV services aan waarbij we advies en ondersteuning bieden om dit te realiseren. * Je bent verantwoordelijk voor de validatie van geautomatiseerde systemen binnen de Life Sciences sector * Je valideert softwaretoepassingen zoals MES, LIMS, ERP, SCADA, BMS, EBR en documentbeheersystemen * Opstellen en reviewen van validatiedocumenten zoals URS, validatieplannen, rapporten, protocollen en risicoanalyses. * Waarborgen van de naleving van GMP, GAMP5, EudraLex Vol. 4 en USA FDA 21 CFR Part 210, 211 en 11-normen. * Pas GAMP5-richtlijnen toe met een risicogebaseerde aanpak en oog voor kwaliteit en duidelijkheid * Samenwerken met cross-functionele teams, waaronder QA, IT, engineering en productie of labo * Zorgen voor up-to-date kennis van de nieuwste trends en ontwikkelingen binnen CSV en relevante regelgeving. ## Related Videos - [The Avengers Initiative (Practical Ethics for Software Engineers)](https://www.wearedevelopers.com/videos/2070-the-avengers-initiative-practical-ethics-for-software-engineers) - [Exploring 5 Key Applications of AI Abundance with Blockchain Assurance](https://www.wearedevelopers.com/videos/971-exploring-5-key-applications-of-ai-abundance-with-blockchain-assurance) - [Official Opening of WeAreDevelopers World Congress 2026](https://www.wearedevelopers.com/videos/100000-official-opening-of-wearedevelopers-world-congress-2026) - [Startup Presentation: StorX - Future of Cloud Storage](https://www.wearedevelopers.com/videos/1176-startup-presentation-storx-future-of-cloud-storage) - [Modern Data Architectures need Software Engineering](https://www.wearedevelopers.com/videos/1030-modern-data-architectures-need-software-engineering) - [GenAI Security: Navigating the Unseen Iceberg](https://www.wearedevelopers.com/videos/1744-genai-security-navigating-the-unseen-iceberg) ## Related Articles - [How to land a developer job in Amsterdam](https://www.wearedevelopers.com/magazine/36-how-to-land-a-developer-job-in-amsterdam) - [Best Companies in the Netherlands: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/193-best-companies-in-the-netherlands-top-25-companies-in-2023) - [How to Find Tech Jobs in Amsterdam](https://www.wearedevelopers.com/magazine/279-how-to-find-tech-jobs-in-amsterdam) - [The Netherlands – Europe’s powerhouse for software development?](https://www.wearedevelopers.com/magazine/31-the-netherlands-europe-s-powerhouse-for-software-development) - [Software Developer Salary in The Netherlands [2023]](https://www.wearedevelopers.com/magazine/217-software-developer-salary-in-the-netherlands-2023) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again)