CSV Validation Engineer

📋 Description

• Lead risk-based validation for complex systems and integrations across cloud, APIs, databases, and
• Develop and execute CSV deliverables: plans, specs, risk assessments, test protocols, IQ/OQ/PQ
• Translate requirements into objective, testable acceptance criteria with traceability.
• Ensure regulatory alignment with 21 CFR Part 11, EU GMP, GAMP 5, ALCOA+.
• Assess data flows, transformations, and data integrity to prevent loss or misattribution.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers.

🎯 Requirements

• 10+ years of computerized system validation in GxP environments.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+.
• Experience with risk-based validation and CS Assurance for complex systems.
• Hands-on with requirements, risk assessments, validation plans/protocols, traceability, and
• Experience validating configurable software, SaaS, cloud, lab/manufacturing systems, or integrated
• Understanding of electronic records/signatures, audit trails, access controls, data migration.

🎁 Benefits

• Senior-level ownership across validation and regulated tech platforms.
• Exposure to cloud, edge, lab, manufacturing, API, and scientific instruments.
• Shape validation practices in a growing organization.
• Remote-friendly environment with autonomy.
• Grow professionally with evolving regulatory use cases and tech.
• Impact reliability, compliance, and audit readiness of mission-critical systems.