Validation Tester

2 days ago

Farmingdale NY United States, New York Agama Solutions Full-time $50 - $55 Permanent

Free with email or Google

Save this job and keep your search organized

Create a free account to save jobs, create alerts and return to this listing from your dashboard.

Free with email or Google

Title: Validation Tester

Location: Farmingdale, NY

Job Description:

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