Amgen

Sr Associate IS Analyst

Amgen  •  Hyderabad, IN (Onsite)  •  5 days ago
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Job Description

Career Category

Engineering

The Tester is responsible for executing testing and validation activities for clinical data, analytics, and reporting systems, with a strong focus on data validation, pipeline testing, and Agile delivery to ensure high-quality and reliable releases.

Key Responsibilities

  • Execute end-to-end testing (SIT, UAT, IQ, OQ, Dry Runs) including test design, execution, and defect management using VVM/Veeva Vault and ALM
  • Perform data validation across ETL/ELT pipelines, including SQL-based reconciliation, source-to-target validation, and verification of datasets, reports, and dashboards
  • Validate system functionality, data transformations, and integrations across GxP and Non-GxP systems based on business and regulatory requirements
  • Analyze and resolve data issues through defect triaging, production data validation, and ensuring data accuracy and integrity
  • Ensure completeness and correctness of testing artifacts, including test scripts, execution evidence, and defect documentation for audit/inspection readiness
  • Maintain end-to-end traceability (RTM) between requirements, test cases, execution results, and defects
  • Support validation lifecycle activities including impact assessment, risk-based testing approaches, and validation documentation updates
  • Support execution and closure of validation activities aligned with Change Requests (ServiceNow) ensuring proper documentation and approvals
  • Participate in release readiness activities including test summaries, defect reviews, and go/no-go decisions
  • Collaborate with Agile teams (BA, Dev, QA, Product) to deliver sprint testing outcomes and ensure timely, high-quality releases
  • Contribute to continuous improvement of testing and validation practices, including standardization and automation-aligned approaches

Required Qualifications

  • 5–8 years of experience in testing, QA, or data validation roles
  • Strong experience in test case design, execution, defect lifecycle management, and test documentation
  • Experience with testing tools such as HP ALM, JIRA, and Confluence
  • Familiarity with functional, integration, and data validation testing approaches
  • Experience working in Agile/Scrum delivery models
  • Strong analytical, debugging, and problem-solving skills
  • Ability to work with cross-functional teams and deliver within sprint timelines

Must Have

  • Strong SQL expertise for data validation, reconciliation, joins, aggregations, and exception analysis
  • Hands-on experience testing ETL/ELT pipelines (Databricks or similar) and validating data across relational databases
  • Experience working with AWS data services (S3 ingestion/storage) and SQL tools (DBeaver or similar)
  • Strong understanding of source-to-target validation, data quality checks, and data defect analysis
  • Experience preparing test evidence and supporting validation execution in controlled environments

Good to Have

  • Knowledge of Computer System Validation (CSV)
  • Understanding of Risk-Based Validation (RBV)
  • Familiarity with GxP and 21 CFR Part 11
  • Experience with Veeva Vault / VVM

Preferred Skills

  • Experience in clinical data, analytics, or reporting systems
  • Familiarity with data warehouse / data lake validation concepts
  • Exposure to test automation or automation-aligned practices
  • Strong documentation and communication skills
Amgen

About Amgen

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.

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Industry
Biotech & Life Sciences
Company Size
10,000+ employees
Headquarters
Thousand Oaks, CA
Year Founded
1980
Website
amgen.com
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