CSV Validation Engineer

📋 Description

• Lead risk-based computerized system validation across cloud applications, edge devices, scientific
• Develop and execute validation strategies and deliverables, including validation plans
• Ensure regulatory compliance (FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+).
• Assess data flows, security controls, and evidence to maintain validated state and inspection-ready
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers throughout the
• Support risk-based validation practices and modern Computer Software Assurance across GxP

🎯 Requirements

• 10+ years in computerized system validation within pharmaceutical, biotech, life sciences, or
• Strong knowledge of regulatory frameworks and validation artifacts (URs, risk assessments
• Experience validating configurable software, SaaS, cloud platforms, laboratory/manufacturing
• Deep understanding of electronic records/signatures, audit trails, access controls, data migration
• Ability to review architectures, data flows, API specs, and test evidence; strong analytical and
• Experience in Agile environments with automated engineering tests as validation evidence is a plus.

🎁 Benefits

• Senior-level ownership across CSV validation and regulated platforms.
• Hands-on work with cloud, edge, laboratory, manufacturing, API, and scientific-instrument
• Opportunity to mature validation processes in a growing team.
• Remote-friendly environment with autonomy and collaboration across cross-functional teams.
• Exposure to modern risk-based validation and Computer Software Assurance practices.
• Professional growth through evolving technologies and regulatory use cases.