CSV Validation Engineer

📋 Description

• Senior, hands-on validation role for complex GxP-regulated environments.
• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Ensure validated state with inspection-ready evidence and traceability.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers across the
• Improve validation practices, structure, and evidence using modern principles.
• Support regulatory inspections and customer audits with clear validation strategies and evidence.

🎯 Requirements

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

🎁 Benefits

• Senior-level ownership across 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 CSA practices.
• Professional growth with evolving technologies and regulatory use cases.