CSV Validation Engineer

📋 Description

• Senior, hands-on validation role for complex platforms in GxP environments
• Lead risk-based computerized system validation across cloud apps, edge devices, instruments, APIs
• Ensure regulated systems are fit for use, secure, and backed by inspection-ready evidence
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers across the
• Understand architectures, data flows, integrations, and system behavior to mature validation

🎯 Requirements

• 10+ years of computerized system validation in pharma/biotech or similar GxP environment
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+ data-integrity
• Experience applying risk-based validation and Computer Software Assurance
• Hands-on with user requirements, risk assessments, validation plans, protocols, 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 computerized validation and regulated platforms
• Exposure to cloud, edge, lab, manufacturing, API, and instrument environments
• Opportunity to influence validation processes in a growing organization
• Remote-friendly environment with autonomy and responsibility
• Apply modern risk-based validation and Computer Software Assurance practices
• Professional growth with evolving tech, regulatory requirements, and complex use cases