CSV Validation Engineer

📋 Description

• Senior, hands-on validation role for complex technology platforms in GxP environments.
• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Ensure regulated systems are fit for use, secure, and supported by inspection-ready evidence.
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers across the
• Develop practical validation strategies, improve traceability, and leverage modern engineering

🎯 Requirements

• 10+ years of computerized system validation experience in pharma/biotech or GxP environments.
• 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 to complex systems.
• Hands-on with requirements, risk assessments, validation plans, protocols, traceability
• Experience validating configurable software, SaaS, cloud platforms, lab/manufacturing systems, or
• Strong ability to review architectures, data flows, APIs, engineering evidence, and change impacts.

🎁 Benefits

• Remote-friendly environment with autonomy and responsibility.
• Opportunity to influence validation processes in a growing organization.
• Cross-functional collaboration with technical, product, quality, and customer teams.
• Hands-on exposure to cloud, edge, lab, manufacturing, API, and scientific-instrument environments.
• Growth through exposure to evolving technologies and regulatory requirements.
• Direct impact on reliability, compliance, and audit readiness of mission-critical systems.