Validation Analyst
Location: Bangalore, Karnataka
Department: Validation Services
Employment Type: Full-Time | Mid-level
About Sitero:
Sitero is a rapidly growing leader in Clinical services and software solutions for the life sciences industry. With deep expertise across therapeutic areas and a commitment to technology-driven innovation, we support early to late-phase clinical trials while emphasizing safety, compliance, and operational excellence.
Position Overview:
We are seeking a Validation Analyst to support the planning and execution of validation activities for both off-the-shelf and custom software integrations within FDA-regulated environments. This role will be instrumental in ensuring the compliance, accuracy, and functionality of systems used across clinical research and technology platforms.
Key Responsibilities:
Plan and perform software validation (IQ, OQ, PQ) for applications in GxP environments.
Execute end-to-end validation of APIs and integrations using tools such as Postman and SOAP UI.
Validate AI-driven software workflows to ensure operational integrity and regulatory compliance.
Develop test plans, test scripts, and traceability matrices.
Leverage Azure DevOps to manage requirements, track execution, and maintain documentation.
Ensure compliance with FDA 21 CFR Part 11, GxP, and related global regulatory frameworks.
Validate applications deployed on cloud platforms (IaaS, PaaS, SaaS) ensuring performance, security, and data integrity.
Support system risk assessments and implement risk-based validation strategies.
Document validation activities thoroughly for internal review and external audits.
Mentor junior team members and support best practice development.
Qualifications:
Education:
Bachelor’s degree in Computer Science, Engineering, or related technical field.
Experience:
2–3 years of hands-on experience in:
API & integration testing
AI software validation
Working in regulated industries (e.g., pharmaceuticals, healthcare).
Proficiency in Postman and SOAP UI.
Working knowledge of Azure DevOps for test management.
Experience validating applications in cloud-hosted environments.
Strong familiarity with FDA 21 CFR Part 11, GxP, and risk-based validation methodologies.
Understanding of SDLC, Agile/Scrum/SAFe frameworks.
Preferred Skills:
Experience with CI/CD pipelines.
Familiarity with database validation and data migration projects.
Broader exposure to API testing and automation frameworks.
Working Conditions:
Standard Hours: Monday – Friday, 40 hours/week (+1 hour lunch); additional hours as needed.
Shift Flexibility: Willingness to work in shifts when required.
Compensation & Benefits:
Competitive base salary with variable pay
Paid time off and public holidays
Healthcare & retirement benefits
Continuous learning and career growth opportunities
Estimated Salary: ₹8–12 LPA
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