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🔍 Computer System Validation (CSV) Specialist 📍 Location : Hybrid, NL 🕓 Type : Full-time Are you passionate about ensuring that computerized systems in life sciences are compliant, reliable, and audit-ready? Do you enjoy working at the intersection of technology, quality, and regulations? We are looking for a Computer System Validation (CSV) Specialist who’s ready to dive into the world of GxP systems and play a vital role in ensuring compliance, integrity, and reliability — from implementation to audit. You’ll apply GAMP5 principles and champion data integrity across the full system lifecycle, helping clients meet the highest regulatory standards with confidence. This role is perfect for someone who’s energized by solving complex challenges, enjoys collaborating across teams, and isn’t afraid to go the extra mile to deliver results that matter. If you’re ready to make an impact — and grow while doing it — we’d love to hear from you. 💡 What’s in it for you? Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise. Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued. 🏢 What you’ll be doing Take ownership of validation activities from start to finish — ensuring every GxP-relevant system is set up and running in full compliance Apply GAMP5 guidelines  using a  risk-based approach with quality and clarity Write and review  user requirements, validation plans, protocols, reports and risk assessments regarding computerized systems with precision, knowing the details make the difference Champion data integrity across everything you do, embedding ALCOA+ principles into both systems and culture Collaborate  with QA, IT, engineering, and operations and elevate  partnership Planning periodic reviews and revalidation , ensuring our systems remain reliable and inspection-ready Execute the required tests in collaboration with Production, QC Be the go-to expert during audits and inspections, confidently representing the work you stand behind Tackle change controls with a can-do attitude, maintaining validated status without losing momentum Assess supplier provided software systems with a critical yet constructive eye — making sure external solutions align with our internal standards Share your knowledge generously by training and guiding colleagues — helping others grow while you do the same 💪 What you bring You hold a Bachelor’s or Master’s degree in a scientific or engineering discipline (e.g., bio-engineering, bioinformatics, industrial or civil engineering) — and you're eager to put it to meaningful use You bring hands-on experience in the Life Sciences industry or in software-driven projects, where compliance and quality matter You feel at home working with IT systems, software , and especially Manufacturing Execution Systems (MES) — you don’t just use them, you understand how they work and why they matter You have a solid understanding of related guidelines (GAMP 5 (ISPE), USFDA 21 CFR Part 11 en Eudralex Annex 11) and know how to apply them in a regulated environment You are detail-oriented by nature,