Validation Testing Engineer

Job Title : Validation Testing Engineer

Experience : 3-5+ Years

Location : Pune, India (Hybrid)

Job Summary :

You will be responsible for designing, executing, and documenting validation testing processes across multiple systems and platforms.

- Contribute to the overall Computer System Validation (CSV) deliverables of the project.

- Develop, execute, and maintain test scenarios, test cases, and validation scripts in alignment with project requirements.

- Select appropriate testing methodologies, techniques, and evaluation criteria to ensure thorough system validation.

Draft, review, and approve validation documents such as :

- User Requirements Specifications (URS)

- Functional Specifications (FS)

- Design Specifications (DS)

- Installation Qualification (IQ)

- Operational Qualification (OQ)

- Performance Qualification (PQ)

- Traceability Matrices

- Configuration Documentation

- Error Logs

- Validation Summary Reports

- Ensure compliance with applicable regulatory standards such as 21 CFR Part 11, EU Annex 11, and GxP requirements.

- Collaborate closely with QA, development, and business teams to ensure test coverage and traceability.

- Participate in audits and inspections, providing necessary validation documentation and support.

- Maintain validation lifecycle documentation in line with corporate and regulatory standards.