Validation Tester

SolutionIT

Not Interested
Bookmark
Report This Job

profile Job Location:

Farmingdale, NY - USA

profile Monthly Salary: Not Disclosed
Posted on: 17 hours ago
Vacancies: 1 Vacancy

Job 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)
  • Bachelors 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

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 inclu...
View more view more

Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing