CSV Validation Engineer

📋 Description

• Senior validation role for complex tech platforms in GxP environments.
• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Ensure evidence is inspection-ready and traceable across the full lifecycle.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers.
• Mature validation practices; introduce structure and traceability improvements.

🎯 Requirements

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

🎁 Benefits

• Senior-level ownership across validation areas.
• Exposure to cloud, edge, lab, manufacturing, API, and instrument environments.
• Influence validation processes in a growing org.
• Remote-friendly work with autonomy and responsibility.
• Grow through evolving tech, regulatory changes, and complex use cases.
• Contribute to reliability, compliance, and audit readiness.