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Amgen Technology Private Limited

Validation Engineering I

1-8 Years
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  • Posted 12 days ago
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Job Description

Key Deliverables:

  • Develop and execute validation protocols (IQ/OQ) for GxP-compliant systems
  • Design automated test suites for APIs, data pipelines, and custom software
  • Collaborate with cross-functional teams to ensure validation and documentation compliance
  • Maintain validation documentation aligned with Amgen SOPs and regulatory standards

Role Responsibilities:

  • Participate in Agile test planning, estimation, and execution
  • Analyze test results and drive root cause analysis with development teams
  • Ensure system validation aligns with 21 CFR Part 11 and GMP guidelines
  • Lead validation improvement initiatives and contribute to QA automation framework

About Company

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 discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average, and we are also part of the Nasdaq-100 Index, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

Job ID: 119662701