Test Validation Engineer

Hiring Validation Test Engineer

Job Title: Validation Test Engineer

Job Type: Full-time

Location: Kokapet, Hyderabad (Work from Office only)

Experience: 3–5 Years

Job Summary

We are looking for a detail-oriented Validation Test Engineer with hands-on experience in end-to-end product testing and Computer System Validation (CSV). The candidate will be responsible for testing product modules, validating functionality against requirements, identifying and reporting defects, coordinating with Development teams for resolution, and performing retesting and regression testing . The role also involves preparing and executing validation documentation to ensure compliance with applicable GxP regulatory requirements and industry standards.

Roles and Responsibilities

• Perform end-to-end product testing across individual modules, features, workflows, and integrated functionalities.
• Understand product requirements and design comprehensive test scenarios, test cases, and test data covering positive, negative, boundary, and exception scenarios.
• Execute functional, integration, regression, exploratory, and user acceptance testing (UAT), as applicable.
• Verify application functionality, data integrity, workflow transitions, user roles and permissions, audit trails, electronic signatures, and other relevant system features.
• Identify, document, and report defects with clear steps to reproduce, expected versus actual results, screenshots, and supporting evidence.
• Log, prioritize, assign, and track defects in Jira; follow up with Development teams to ensure timely resolution.
• Perform defect retesting after fixes are deployed and conduct regression testing to ensure existing functionalities remain unaffected.
• Maintain test execution records, defect status, test evidence, and testing progress reports.
• Review URS and FRS documents to develop and execute OQ, PQ, and UAT test cases, ensuring appropriate requirement coverage and traceability.
• Author and maintain validation deliverables, including Validation Plan, URS, FRS, Functional Risk Assessment, 21 CFR Part 11 Assessment, Traceability Matrix, and Validation Summary Report.
• Ensure compliance with Good Documentation Practices (GDP), GAMP 5 guidelines, GxP requirements, and applicable regulatory standards throughout the system lifecycle.
• Collaborate with Development, QA, and Validation teams to investigate issues, clarify requirements, improve product quality, and support release readiness.

Required Skills and Qualifications

• 3–7 years of relevant experience in software/product testing and/or Computer System Validation.
• Hands-on experience in end-to-end application testing, test case design, execution, defect reporting, retesting, and regression testing.
• Practical experience using Jira for defect logging, tracking, and closure.
• Ability to analyze requirements, identify edge cases, and validate complex workflows across multiple modules.
• Experience in drafting and executing OQ/PQ protocols and validation test cases.
• Good understanding of the CSV lifecycle, risk-based validation, and requirement traceability.
• Knowledge of GAMP 5, GxP best practices, Good Documentation Practices, and 21 CFR Part 11.
• Strong analytical, documentation, communication, and problem-solving skills, with the ability to work independently and collaboratively.

Educational Qualifications

Bachelor’s degree in Science, Engineering, or a related discipline is required.