Validation Analyst – Sitero – Bangalore (Full-Time)
Location: Bangalore, Karnataka
Department: Validation Services
Employment Type: Full-Time
Company Overview:
Sitero is a fast-growing clinical services and software solutions company supporting the life sciences industry. We offer technology-enabled services that enhance the efficiency and integrity of clinical trials across a wide range of therapeutic areas, with a focus on ethics, compliance, and innovation.
Position Summary:
As a Validation Analyst, you will be responsible for planning, executing, and documenting validation efforts for software systems and integrations, especially in FDA-regulated environments. You will work on validating both traditional and AI-driven software, ensuring compliance with industry standards such as FDA 21 CFR Part 11 and GxP.
Key Responsibilities:
Plan and execute software validation activities (off-the-shelf and custom integrations).
Perform end-to-end validation using tools like Postman and SOAP UI.
Validate AI-driven software to ensure accuracy, performance, and regulatory compliance.
Develop validation protocols including IQ, OQ, PQ, test cases, and traceability matrices.
Use Azure DevOps for test case management and documentation.
Ensure validation in cloud-hosted environments meets compliance standards.
Conduct system risk assessments and implement risk mitigation strategies.
Ensure alignment with FDA 21 CFR Part 11, GxP, and industry best practices.
Collaborate across Software Development, QA, Regulatory Affairs, and IT teams.
Produce thorough validation reports for internal/external audits.
Mentor junior analysts and promote best practices in validation processes.
Qualifications & Experience:
Bachelor’s degree in Computer Science, Engineering, or related technical field.
2–3 years of experience in API testing, integration validation, and AI solution workflows.
Proficient in Postman, SOAP UI, and Azure DevOps.
Experience in cloud software validation (IaaS, PaaS, SaaS).
Solid understanding of SDLC, Agile, Scrum, and SAFe validation processes.
Familiarity with regulatory standards: FDA 21 CFR Part 11, GxP.
Strong communication skills and collaborative mindset.
Preferred Skills:
Experience with CI/CD pipelines.
Familiarity with database validation and data migration.
API testing expertise.
Estimated Salary: ₹8 – ₹11 LPA (based on experience)
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