Software Test Engineer Work Flexibility: Hybrid Job Summary: The Software Testing u0026 nComputer System Validation (CSV) Engineer is responsible for manual testing of software products and tools required at developmental and verification stages along with ensuring computerized systems used in regulated environments (e.g., GMP, GCP, GLP) are validated in compliance with applicable regulatory requirements such as 21 CFR Part 11, Annex 11, GAMP 5. nnWhat you will do Design, develop, and maintain detailed test cases, checklists, and test data nExecute test cases for web, mobile, and desktop applications nIdentify, document, and track defects using a bug-tracking tool (e.g., Jira). nnPerform different types of testing: Functional, Regression, Integration, System, Sanity, etc nParticipate in review meetings, sprint planning, and daily stand-ups Develop and execute validation strategies and plans for recent and existing computerized systems. nnCreate and maintain validation documents including: User Requirements Specifications (URS) nFunctional Specifications (FS) nRisk Assessment nValidation Plans (VP) nIQ/OQ/PQ Protocols and Reports nTraceability Matrix. Perform impact assessments and change control activities for validated systems.



Provide training and guidance on CSV processes and best practices. Maintain validation documentation in alignment with company procedures and regulatory expectation What you will need: Required: Experience- 1yrs to 3 years of experience in manual software testing and computer system validation within regulated industries (pharma, biotech, medical devices). Bachelors degree in engineering, Computer Science, Life Sciences, or related field. Valuable understanding of SDLC, and defect life cycle; nnExperience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications. nnPreferred : Understanding of software development life cycle (SDLC) and risk-based validation approaches nCSV certifications (e.g., ISPE, PDA) or GxP training nISTQB Certification Experience in data integrity assessments and remediation projects nFamiliarity with cloud-based systems and cybersecurity considerations. Robust knowledge of GAMP 5, 21 CFR Part 11, Annex 11. Excellent documentation, reporting, communication, and project management skills. nnTravel Percentage: None Experience Level Mid Level . .

📌 Software Test Engineer Manual Testing u0026 Computer System Validation Gurugram
🏢 Stryker India Private
📍 Gurugram