Job Description

<b>Job Title: Validation Tester - CFR Part 11 Compliance Location:</b> Farmingdale, NY - 3 days in office. Duration: 6-12 months Work Location: Hybrid - Onsite presence required for collaboration with QA team About the Role: Client 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 m...

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