CSV Validation Engineer

📋 Description

• Senior validation lead for complex technology platforms in GxP environments
• Oversee risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Ensure evidence remains inspection-ready across lifecycle
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers
• Balance regulatory requirements with practical, delivery-focused validation

🎯 Requirements

• 10+ years in computerized system validation in pharma/biotech or GxP env
• Deep knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+
• Experience with risk-based validation and Computer Software Assurance
• Hands-on with URs, risk assessments, validation plans, protocols, traceability
• Experience validating configurable software, SaaS, cloud, lab/manufacturing systems
• Strong doc skills and ability to reviews architectures, data flows, APIs

🎁 Benefits

• Senior-level ownership across validation platforms
• Exposure to cloud, edge, lab, manufacturing, API, and instruments
• Opportunity to mature validation practices in a growing org
• Remote-friendly with cross-functional collaboration
• Grow via modern risk-based validation and CSA practices
• Contribute to reliability, compliance, and audit readiness