Validation Tester

Job Description About the Role Seeks an experienced Validation Tester to execute CFR Part 11 compliance testing supporting FDA approval processes for key pharmaceutical clients including Vertex. This hybrid position requires proven life sciences validation experience with immediate availability to begin certification work across multiple systems. Key Responsibilities · Execute validation testing for electronic records systems per §11.10 (accuracy, audit trails, data integrity) · Validate electronic signature functionality per §11.50 and §11.70 (authentication, non-repudiation) · Support FDA approval process through comprehensive CFR Part 11 certification across identified systems · Develop and execute IQ/OQ/PQ protocols and validation documentation · Create and maintain validation master plans, requirements traceability matrices (RTM) · Conduct risk-based validation and testing · Maintain FDA inspection-ready documentation packages · Collaborate with QA leadership to define validation ...