CSV Validation Engineer

📋 Description

• Lead risk-based computerized system validation across cloud apps, edge devices, APIs, databases
• Develop and execute CSV deliverables: validation plans, requirements, protocols, traceability
• Translate regulatory/business needs into objective, testable acceptance criteria with full
• Ensure compliance with GxP/regulatory expectations (FDA 21 CFR Part 11, EU GMP Annex 11, PIC/S
• Collaborate with Engineering, Product, Quality, Operations, suppliers, and customers to maintain
• Prepare validation packages for audits, regulatory inspections, and customer reviews.

🎯 Requirements

• 10+ years in computerized system validation in pharmaceutical/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 experience with requirements, risk assessments, validation plans, protocols, traceability
• Experience validating configurable software, SaaS, cloud platforms, lab/manufacturing systems, or
• Strong understanding of electronic records/signatures, audit trails, access controls, data

🎁 Benefits

• Senior-level ownership across CSV and regulated technology platforms.
• Exposure to cloud, edge, lab, manufacturing, API, and scientific-instrument environments.
• Opportunity to mature validation practices in a growing organization.
• Remote-friendly environment with autonomy and responsibility.
• Chance to apply modern risk-based validation and Computer Software Assurance.
• Professional growth through exposure to evolving technologies and regulatory use cases.