CSV Validation Engineer

📋 Description

• Lead risk-based validation across cloud apps, edge devices, APIs, databases, and enterprise
• Create and maintain validation packages, including plans, test protocols, traceability, deviations
• Translate regulatory/business requirements into clear acceptance criteria; ensure traceability of
• Collaborate with Engineering, Product, Quality, Operations, and suppliers to review documentation
• Support regulatory audits and inspections with clear validation evidence and documentation.
• Drive practical, delivery-focused validation practices aligned with modern Computer Software

🎯 Requirements

• 10+ years of computerized system validation in pharmaceutical/GxP environments with end-to-end
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+ principles.
• Experience applying risk-based validation and CSAs to complex systems; hands-on with requirements
• Experience validating configurable software, SaaS, cloud platforms, lab/manufacturing systems, or
• Understanding of electronic records, signatures, audit trails, access controls, data migration, and
• Ability to review technical docs, architectures, data flows, API specs, and engineering test

🎁 Benefits

• Senior-level opportunity with ownership across validation and regulated tech platforms.
• Exposure to cloud, edge, lab, manufacturing, API, and scientific-instrument environments.
• Opportunity to mature validation practices in a growing organization.
• Remote-friendly work environment with autonomy and responsibility.
• Grow professionally with evolving technologies and regulatory landscapes.
• Impact reliable, compliant, and audit-ready systems for critical operations.