Software Test Engineer Work Flexibility: Hybrid Job Summary: The Software Testing &
Computer 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.

What you will do Design, develop, and maintain detailed test cases, checklists, and test data
Execute test cases for web, mobile, and desktop applications
Identify, document, and track defects using a bug-tracking tool (e.g., Jira).

Perform different types of testing: Functional, Regression, Integration, System, Sanity, etc
Participate in review meetings, sprint planning, and daily stand-ups Develop and execute validation strategies and plans for current and existing computerized systems.

Create and maintain validation documents including: User Requirements Specifications (URS)
Functional Specifications (FS)
Risk Assessment
Validation Plans (VP)
IQ/OQ/PQ Protocols and Reports
Traceability 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). Bachelor’s degree in engineering, Computer Science, Life Sciences, or related field. Positive understanding of SDLC, and defect life cycle;

Experience with bug-tracking/project management tools (e.g., Jira, Devops); and validating systems such as Valgenesis, and custom applications.

Preferred : Understanding of software development life cycle (SDLC) and risk-based validation approaches
CSV certifications (e.g., ISPE, PDA) or GxP training
ISTQB Certification Experience in data integrity assessments and remediation projects
Familiarity with cloud-based systems and cybersecurity considerations. Solid knowledge of GAMP 5, 21 CFR Part 11, Annex 11. Excellent documentation, reporting, communication, and project management skills.

Travel Percentage: None Experience Level Mid Level

📌 Software Test Engineer Manual Testing & Computer System Validation Gurugram (India)
🏢 Stryker India Private
📍 India