CSV Validation Engineer

📋 Description

• Lead risk-based validation across cloud apps, edge devices, APIs, databases, and regulated systems.
• Develop and execute validation plans, requirements, test protocols, and evidence packages.
• Ensure traceability of requirements, risks, tests, defects, and evidence.
• Assess data flows, transformations, mappings, and data integrity scenarios.
• Evaluate compliance with 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, and ALCOA+.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers to cover GxP

🎯 Requirements

• 10+ years in computerized system validation within pharmaceutical/biotech/GxP-regulated env.
• Strong knowledge of FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S GMP, GAMP 5, ALCOA+.
• Experience applying risk-based validation and Computer Software Assurance.
• Hands-on experience with requirements, risk assessments, validation plans, protocols, and IQ/OQ/PQ
• Experience validating configurable software, SaaS, cloud, lab/manufacturing systems, or integrated
• Understanding of electronic records/signatures, audit trails, access controls, data migration

🎁 Benefits

• Senior-level opportunity with ownership across CSV and regulated tech.
• Exposure to cloud, edge, lab, manufacturing, API, and scientific instrument environments.
• Opportunity to influence validation processes within a growing org.
• Remote-friendly, autonomous working environment.
• Apply modern risk-based validation and Computer Software Assurance practices.
• Professional growth through exposure to evolving tech and regulatory use cases.