Job
Description
Job Title: Validation Analyst Location: Bangalore Function: Validation Services ESSENTIAL DUTIES AND RESPONSIBILITIES Plan, execute, and document software validation activities for both off-the-shelf and custom integrations in an FDA-regulated environment. Conduct comprehensive end-to-end validation of software integrations using tools such as Postman and SOAP UI to verify data accuracy, compliance, and system interoperability. Perform validation of AI-driven software integrations to ensure functionality, integrity, and regulatory alignment. Develop and execute validation test plans, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, as well as test scripts and traceability matrices. Collaborate with cross-functional teams including Software Development, Quality Assurance, Regulatory Affairs, and IT to align validation activities with internal standards and external regulatory requirements. Utilize Azure DevOps for managing requirements, tracking test execution, and maintaining validation documentation. Validate software in cloud-hosted environments, ensuring compliance with security, performance, and data integrity standards. Participate in system risk assessments and contribute to the development of risk mitigation strategies. Ensure strict adherence to FDA 21 CFR Part 11, GxP, and other applicable regulatory guidelines throughout all validation processes. Document all validation efforts thoroughly and produce detailed reports to support internal reviews and external audits. Provide guidance and mentorship to junior validation analysts, promoting best practices and continuous improvement. EDUCATION AND EXPERIENCE REQUIRED: Education: Bachelor s degree in computer science, Engineering, or a related technical field. Minimum of 2-3 years of experience in API testing, Integration testing, and AI-driven solutions and workflows, preferably in a regulated industry. Experience: 2-3 years of hands-on experience in API testing, integration testing, and AI software validation, preferably within a regulated industry (e.g., life sciences, healthcare, or pharmaceuticals). Proficient in using Postman and SOAP UI for API and web service validation. Experience validating AI-driven solutions and workflows. Demonstrated expertise with Azure DevOps for test case management, execution tracking, and reporting. Solid understanding of cloud deployment models (IaaS, PaaS, SaaS) and best practices for validating applications in cloud environments. Familiarity with FDA regulations, including 21 CFR Part 11 and GxP, as well as risk-based validation methodologies. Strong knowledge of software development life cycles (SDLC) and validation life cycle processes, including Agile, Scrum, and SAFe frameworks. Excellent verbal and written communication skills, with the ability to collaborate effectively across cross-functional teams. Preferred Skills: Familiarity with continuous integration/continuous deployment (CI/CD) pipelines. Experience with database validation and data migration projects. Experience with API testing. COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. EMPLOYMENT TYPE: Full Time, Permanent COMMITMENTS: Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed. Willing to work in shifts as and when needed.
