Validation Tester

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Solution IT Inc. is looking for a Validation Tester for one of its clients in Farmingdale, NY/ Hybrid

Job Title:

Validation Tester

Summary The 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.

Responsibilities:

Execute validation testing for electronic records systems per accuracy, audit trails, data integrity)

Validate electronic signature functionality per 11.50 and 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 Skills

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 Site:

Farmingdale, NY/ Hybrid

Duration: 12 Months

Expected Start Date:

Immediate

Number of Positions: 1

Please send your responses back to

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering and Information Technology

Industries

Software Development