CSV Validation Engineer

📋 Description

• Lead risk-based CSV validation for complex, regulated systems.
• Create and maintain validation deliverables and evidence.
• Translate requirements into testable acceptance criteria and ensure traceability.
• Validate ecosystems: browser apps, cloud, APIs, databases, IoT, and regulated integrations.
• Test data flows, mappings, and recovery to prevent loss or misattribution.
• Align with FDA/EC GMP and ALCOA+ data-integrity principles.

🎯 Requirements

• 10+ years in computerized system validation in GxP environments.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ALCOA+.
• Experience applying risk-based validation and CSA to complex systems.
• Hands-on with requirements, risk assessments, validation plans, protocols, and IQ/OQ/PQ docs.
• Experience validating configurable software, SaaS, cloud, lab/manufacturing systems.
• Understanding of electronic records, signatures, audits, access controls, data migration.

🎁 Benefits

• Senior-level ownership across validation and regulated platforms.
• Hands-on work with cloud, edge, API, and instrumentation environments.
• Shape validation processes in a growing org.
• Collaborate across technical, product, quality, and customer teams.
• Remote-friendly with autonomy and responsibility.
• Apply modern risk-based validation and CSA practices.