CSV Validation Engineer

📋 Description

• Lead risk-based validation across cloud apps, edge devices, APIs, and integrations.
• Develop and maintain validation plans, protocols, and evidence.
• Translate regulatory requirements into objective acceptance criteria.
• Ensure traceability of requirements, tests, defects, and evidence.
• Collaborate with Engineering, Product, Quality, and Operations teams.
• Work in a GxP-regulated environment to ensure inspection-ready evidence.

🎯 Requirements

• 10+ years' CSV/ computerized system validation in GxP.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, ALCOA+.
• Experience with risk-based validation and CSA approaches.
• Hands-on with UCs, risk assessments, validation plans, and IQ/OQ/PQ docs.
• Experience validating configurable software, SaaS, cloud, and enterprise integrations.
• Excellent writing and cross-functional collaboration skills.

🎁 Benefits

• Senior-level ownership across validation platforms.
• Remote-friendly environment with autonomy.
• Opportunity to mature validation practices and evidence.
• Exposure to evolving regulatory requirements and complex use cases.
• Impact on reliability, compliance, and audit readiness.