# Specialist IS Business Analyst Source: https://realanalystjobs.com/job/specialist-is-business-analyst-amgen-80093bdb Specialist IS Business Analyst at Amgen, an on-site role based in Hyderabad, India. Posted on 15 September 2026, read from Amgen's own careers page (Workday), which RealAnalystJobs re-checks daily and removes the role when it closes. Updated 14 November 2026. ## Key facts - Company: [Amgen](https://realanalystjobs.com/companies/amgen) - Location: Hyderabad, India - Work mode: On-site - Posted: Sep 15, 2026 - Employment type: Full time - Source: Amgen's careers page (Workday), re-checked daily ## Visa sponsorship The posting does not say. Amgen had H-1B petitions approved for 306 workers in fiscal year 2026 (USCIS). That is history, not a promise for this role. [See the record](https://realanalystjobs.com/companies/amgen#h1b-record) ## About this role Career Category Information Systems Job Description Position Summary Lead the validation team in a GMP High Salesforce application and serve as the accountable leader for validation governance, GxP compliance, RTM traceability, inspection readiness, and quality oversight. Drive compliant delivery through strong validation leadership, risk-based decision making, and operational excellence while developing a high-performing validation team. Key Responsibilities • Lead validation strategy, governance, and execution for GxP-regulated applications, computerized systems, and digital platforms. • Ownership & oversight for validation activities, ensuring compliance with internal SOPs, regulatory requirements, and industry standards. • Author & ownership of validation deliverables including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Validation Summary Reports (VSRs), and Requirements Traceability Matrices (RTMs). • Establish and maintain end-to-end traceability between requirements, risks, test evidence, defects, and compliance documentation through RTM governance. • Ensure inspection of readiness and support internal audits, regulatory inspections, CAPA, deviation management, and change control activities. • Complete ownership of validation strategy, testing scope and end-to-end system validation. • Lead and mentor Validation Engineers, establishing best practices and driving a quality-first culture. • Partner with Product, Business, Quality, Regulatory, and Technology teams to support compliant and timely delivery of business initiatives. • Drive continuous improvement initiatives to reduce validation cycle time while maintaining compliance and quality standards. Basic Qualifications • Bachelor's or Master's degree in Computer Science, Engineering, Information Systems, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline. • 8+ years of experience in Computer System Validation (CSV), Quality Assurance, or GxP-regulated environments. • 3+ years of experience leading validation teams, validation programs, or quality compliance initiatives. • Experience supporting regulated systems throughout the software development lifecycle (SDLC). Preferred Qualifications • Experience leading validation activities for global, enterprise-scale digital platforms. • Experience implementing Computer Software Assurance (CSA) and risk-based validation methodologies. • Experience validating cloud-based and SaaS platforms. • Experience supporting Agile and product-centric delivery organizations. • Experience driving validation automation and digital transformation initiatives in Life Sciences domain. Required Skills • Computer System Validation (CSV) expertise. • Strong knowledge of GxP regulations, FDA 21 CFR Part 11, Annex 11, and Data Integrity requirements. • Validation lifecycle management including Validation Plans, Risk Assessments, RTM, IQ/OQ/PQ, and VSRs. • Requirements Traceability Matrix (RTM) creation, governance, and compliance management. • Risk-based validation and test strategy development. • Audit and inspection readiness management. • Quality Management Systems (QMS), CAPA, deviation, and change control processes. • Validation management tools such as ALM, Jira, Validation Management (VM), or equivalent platforms. Good-to-Have Skills • Computer Software Assurance (CSA). • GAMP 5 methodology. • Validation of Salesforce, Mulesoft, cloud, and SaaS solutions. • Automated testing and validation frameworks. • DevOps, CI/CD, and release management practices. • Quality metrics, KPI reporting, and trend analysis. . Description from Amgen's public careers feed, reproduced so you can read the role here. Apply on the company's own site; Real Analyst Jobs never submits anything for you. ## How to apply Open [this role on Real Analyst Jobs](https://realanalystjobs.com/job/specialist-is-business-analyst-amgen-80093bdb) and use Apply now there to reach the employer's application. The listing is re-checked against Amgen's careers page daily and removed when it closes. ## Amgen 54 open analyst roles on Real Analyst Jobs. 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