CSV Validation Engineer

📋 Description

• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Create and execute validation deliverables: validation plans, requirements, test protocols
• Translate requirements into objective acceptance criteria and ensure traceability of requirements
• Ensure compliance with regulatory expectations (FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP
• Assess data flows, transformations, and data integrity, ensuring no loss, duplication, or
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers across the

🎯 Requirements

• 10+ years of computerized system validation experience in GxP-regulated environments.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+.
• Experience applying risk-based validation and Computer Software Assurance.
• Hands-on in creating URs, risk assessments, validation plans, protocols, traceability matrices
• Experience validating configurable software, SaaS, cloud platforms, lab/manufacturing systems, or
• Understanding of electronic records/signatures, audit trails, access controls, security, data

🎁 Benefits

• Senior-level opportunity with ownership across validation programs.
• Exposure to cloud, edge, lab, manufacturing, API, and scientific-instrument environments.
• Chance to mature validation practices in a growing organization.
• Remote-friendly environment with autonomy and collaboration across teams.
• Opportunity to apply modern risk-based validation and Computer Software Assurance practices.
• Professional growth through exposure to evolving compliance requirements and complex GxP use cases.