Validation Tester

Farmingdale, NY, US • Posted 5 days ago • Updated 3 hours ago

Full Time

On-site

Fitment

Dice Job Match Score™

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Job Details

Skills

Test Automation
selenium
audit trails
data integrity
manufacturing systems
Defect Management
FDA compliance
21 CFR Part 11
Validation Tester
Computer Systems Validation (CSV)
Life Sciences Validation
GxP Validation
FDA Validation Specialist
Quality Assurance (QA) Validation
FDA Inspection Readiness
Regulatory Submissions
SOX / GxP Controls (as applicable)
IQ / OQ / PQ
Validation Master Plan (VMP)
Requirements Traceability Matrix (RTM)
User Requirements Specification (URS)
Functional Design Specification (FDS)
Risk-Based Validation
Validation Protocol Execution
Validation Certification
Electronic Records Systems
Electronic Signature Validation
Audit Trail Testing
CAPA Management
Pharmaceutical Systems
Medical Devices
Life Sciences QA
Clinical / Manufacturing Systems
FDA Approval Support
Tosca
Electronic Records &amp; Electronic Signatures (ER/ES)
Test Execution &amp; Evidence Collection

Summary

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 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 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

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10290916
Position Id: 2026-12457
Posted 5 days ago

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Validation Tester

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Job Details

Skills

Summary

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