Roles & Responsibilities

- Perform end-to-end validation testing activities for GxP applications in compliance with regulatory requirements.
- Develop, review, and execute validation deliverables including:
- Validation Plans
- Test Strategy & Test Plans
- IQ/OQ/PQ protocols
- Test Scripts
- Traceability Matrix (RTM)
- Validation Summary Reports
- Conduct functional, integration, regression, and user acceptance testing for validated systems.
- Ensure applications comply with applicable GxP, CSV, and regulatory standards.
- Review business requirements, functional specifications, and technical documents to identify test scenarios.
- Execute manual validation test cases and document results with appropriate objective evidence.
- Perform defect management including identification, documentation, tracking, retesting, and closure.
- Support change control, impact assessments, risk assessments, and periodic review activities.
- Collaborate with business users, QA, development teams, and validation stakeholders.
- Maintain validation documentation according to SOPs and quality processes.
- Support audits and regulatory inspections by ensuring complete and compliant validation evidence.

Mandatory Skills
- Minimum 5+ years of experience as a Validation/Test Engineer.
- Hands-on experience working in a GxP-regulated environment is mandatory.
- Strong knowledge of:
- Computer System Validation (CSV)




- GAMP 5 guidelines
- FDA 21 CFR Part 11 compliance
- ALCOA+ principles
- Data Integrity requirements
- Experience in preparing and executing IQ, OQ, and PQ validation documentation.
- Solid understanding of SDLC and validation lifecycle processes.
- Experience with test management and defect tracking tools.

Technical Skills
- Test Management Tools: ALM/QC, Jira, Azure DevOps, or equivalent
- Documentation & Validation Tools: Veeva, TrackWise, ServiceNow, or similar (preferred)
- Database/SQL knowledge preferred
- Understanding of Agile and Waterfall delivery methodologies

Preferred Qualifications
- Experience in pharmaceutical, biotech, clinical, laboratory, or life sciences domains.
- Experience validating applications in Life Sciences domain
- Exposure to automated testing tools is an advantage.
- Knowledge of cloud-based validated systems preferred.

Soft Skills
- Excellent analytical and problem-solving skills.
- Strong attention to detail and documentation quality.
- Good communication skills with experience interacting with global stakeholders.
- Ability to work independently in a regulated environment.

Education: Bachelors degree in computer science, Engineering, Life Sciences, or related discipline.Role & responsibilities

Preferred candidate profile

📌 Testing Validation Engineer (Bengaluru)
🏢 Excelra
📍 Bengaluru