Validation Tester - CFR Part 11 Compliance

Validation Tester - CFR Part 11 Compliance

Location - Farmingdale , NY Hybrid - Onsite presence required for collaboration with QA team

About the Role

Enzo Life Sciences 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 roadmap and system requirements

·         Manage defect tracking with CAPA processes for critical issues

·         Test audit trail requirements i

Required Qualifications

·         5+ years hands-on experience in pharmaceutical, medical device, or life sciences QA

·         Proven track record with 21 CFR Part 11 compliance validation and Computer Systems Validation (CSV)

·         Deep understanding of FDA regulations, GxP requirements, and data integrity

·         Experience supporting FDA approval processes and regulatory submissions

·         Experience with test management tools (Jira, TestRail, qTest, Xray, Zephyr)

·         Proficiency in validation documentation (IQ/OQ/PQ, VMP, RTM, URS/FDS)

·         Bachelor's degree in Life Sciences, Computer Science, or related field

·         Immediate availability to begin engagement

Preferred Qualifications

·         ISTQB, CSQE, or CSTE certification

·         Automation experience (Selenium, Tosca, UFT)

·         CI/CD platforms knowledge (Jenkins, Azure DevOps)

·         Six Sigma or PMP certification

·         Experience with AI-powered testing tools and frameworks

Work Location: Hybrid - Onsite presence required for collaboration with QA team