CSV Validation Engineer

📋 Description

• Lead risk-based validation across cloud apps, edge devices, APIs, databases, and enterprise
• Develop and execute CSV deliverables: validation plans, requirements, test protocols, IQ/OQ/PQ
• Translate regulatory/business needs into acceptance criteria; maintain traceability across
• Validate systems against regulatory expectations (FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP
• Assess data flows, transformations, mappings, and data migration to prevent loss, duplication, or
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers; support

🎯 Requirements

• 10+ years of computerized system validation in pharma/biotech or GxP-regulated environments.
• Strong knowledge of regulatory frameworks and risk-based validation approaches.
• Experience with validating configurable software, SaaS, cloud platforms, lab/manufacturing systems
• Proficiency in documentation: user requirements, risk assessments, validation plans, protocols
• Familiarity with REST APIs, relational databases, SQL, MQTT, data mappings, and multi-vendor data
• Excellent technical writing, analytical, and cross-functional collaboration skills; capable of

🎁 Benefits

• Senior-level opportunity with ownership across CSV and regulated technology platforms.
• Remote-friendly environment with cross-functional collaboration.
• Opportunity to influence validation practices in a growing organization.
• Professional growth through exposure to evolving technologies and regulatory requirements.
• Direct impact on reliability, compliance, and audit readiness of mission-critical systems.