Validation Testing Engineer

3 weeks ago

Pune, Maharashtra, India Impetus Career Consultants Private Limited Full time

Job Title : Validation Testing Engineer

Experience : 3-5+ Years

Location : Pune, India (Hybrid)

Job Summary :


We are looking for a skilled Validation Testing Engineer with over 3-5 years of experience to join our team in Pune. The ideal candidate will contribute to Computer System Validation (CSV) activities, ensuring compliance with regulatory requirements such as 21 CFR Part 11 and EU Annex 11.

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

Key Responsibilities :

- 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.

(ref:hirist.tech)

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