Ashwin Nr
Computer System Validation Engineer at Biontech Se
Based in Germany
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Seniority
Staff
Department
Information Technology
Location
Germany
Industry
Biotechnology Research
Company size
5K
Contact information
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a•••••••@biontech.com
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Background
About Ashwin Nr
Over 10 years of experience in the life sciences industry and a 15-year IT background, specializing in ensuring GxP compliance, data integrity, and audit readiness throughout the system lifecycle. Proven expertise in developing and executing risk-based validation strategies aligned with FDA 21 CFR Part 11, EU GMP Annex 11 and GAMP 5 principles. Skilled in digital transformation, cross-functional collaboration, and stakeholder management within regulated environments. Recognized for leading CSV projects end-to-end — from planning and documentation to implementation and continuous improvement — and for mentoring teams on compliance best practices.
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