CSV Validation Engineer

📋 Description

• Lead risk-based validation across cloud apps, edge devices, APIs, and integrations.
• Develop and maintain CSV deliverables (validation plans, protocols, traceability).
• Ensure regulatory alignment with FDA/EU GMP/GAMP 5 and ALCOA+ data integrity.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers.
• Provide inspection-ready evidence and lifecycle validation support.
• Drive practical, modern validation practices in a growing org.

🎯 Requirements

• 10+ years of computerized system validation in GxP environments.
• Strong knowledge: FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5.
• Experience with risk-based validation and CSV across complex systems.
• Hands-on with requirements, risk assessments, validation plans, and IQ/OQ/PQ docs.
• Experience validating configurable software, SaaS, cloud, and enterprise integrations.
• Excellent written communication and cross-functional collaboration.

🎁 Benefits

• Senior-level ownership across validation and regulated tech.
• Exposure to cloud/edge infra, APIs, and scientific instruments.
• Remote-friendly environment with autonomy and responsibility.
• Opportunity to evolve validation processes and evidence standards.
• Professional growth with evolving regulatory requirements.
• Direct impact on reliability, compliance, and audit readiness.