CSV Validation Engineer

📋 Description

• Lead risk-based CSV validation across cloud apps, edge devices, APIs, databases, and enterprise
• Develop and maintain validation deliverables (plans, requirements, specs, risk assessments, test
• Translate regulatory/business requirements into objective, traceable acceptance criteria.
• Evaluate systems against FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data
• Assess data flows, transformations, mappings, and failure scenarios to prevent data issues.
• Partner with Engineering, Product, Quality, Operations, suppliers, and customers to ensure coverage

🎯 Requirements

• 10+ years in computerized system validation in GxP environments with end-to-end CSV ownership.
• 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 with requirements, risk assessments, validation plans, protocols, traceability
• Experience validating configurable software, SaaS, cloud, lab/manufacturing systems, or integrated
• Understanding of electronic records/signatures, audit trails, access controls, security, data

🎁 Benefits

• Senior-level ownership across CSV and regulated tech platforms.
• Exposure to cloud, edge, lab, API, and instrument environments.
• Influence validation processes within a growing organization.
• Remote-friendly with autonomy and responsibility.
• Grow professionally amid evolving regulations and tech.
• Contribute to reliability and audit readiness of critical systems.