CSV Validation Engineer

📋 Description

• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Develop and execute CSV deliverables: validation plans, requirements, test protocols, traceability
• Translate requirements into objective acceptance criteria; ensure traceability of requirements
• Assess data flows, transformations, mappings, and recovery behavior to prevent data loss or
• Ensure compliance with regulatory expectations (FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers to review

🎯 Requirements

• 10+ years of computerized system validation in pharmaceutical/biotech/life sciences or another
• Strong knowledge of 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data integrity
• Experience with risk-based validation and Computer Software Assurance for complex systems.
• Hands-on experience creating user requirements, risk assessments, validation plans, protocols, and
• Experience validating configurable software, SaaS, cloud platforms, lab/manufacturing systems, or
• Understanding of electronic records/signatures, audit trails, access controls, data migration, and

🎁 Benefits

• Senior-level opportunity with ownership across CSV and regulated tech platforms.
• Hands-on exposure to cloud, edge, laboratory, manufacturing, API, and scientific instruments.
• Opportunity to influence validation processes in a growing organization.
• Remote-friendly environment with autonomy and responsibility.
• Apply modern risk-based validation and Computer Software Assurance practices.
• Professional growth through exposure to evolving technologies and regulatory use cases.