Software Development Engineer- Test II

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.

• →Build and promote test engineering practices, standards, and automation frameworks while fostering a strong quality-first and test automation culture.
• →Design, develop, and maintain automated and manual test cases based on functional and non-functional requirements for enterprise, AI-driven, and workflow automation solutions.
• →Perform testing activities in compliance with GxP and Computer System Validation (CSV) regulations, ensuring proper documentation, execution, traceability, and audit readiness.
• →Create and maintain Requirement Traceability Matrices (RTMs) to ensure complete test coverage and regulatory compliance.
• →Log, track, and manage defects using tools such as HP ALM, Azure DevOps, or Jira, ensuring clear documentation and end-to-end traceability.
• →Execute and support User Acceptance Testing (UAT), Systems Integration Testing (SIT), Operational Qualification (OQ), regression testing, and validation activities across regulated environments.
• →Collaborate with business stakeholders, developers, and validation teams to ensure defects are resolved effectively and quality standards are consistently achieved.
• →Develop and maintain automation test scripts using tools such as UiPath Test Suite, Selenium, Postman, or similar technologies to improve test efficiency and coverage.
• →Maintain comprehensive testing documentation, evidence packages, and validation artifacts to support compliance, inspections, and audit readiness.
• →Perform end-to-end testing of LLM-powered, Agentic AI, and Custom GPT solutions, including prompt validation, response accuracy, grounding verification, hallucination detection, and Responsible AI compliance assessments.
• →Validate AI-generated artifacts, automated workflows, and intelligent automation outputs to ensure reliability, consistency, data integrity, explainability, and compliance within GxP-regulated processes.
• →Implement risk-based testing strategies for AI and automation platforms, focusing on quality, security, compliance, traceability, model performance, and regulatory requirements.
• →Understanding end-to-end AI/ML lifecycle.

• Any degree and 5 to 9 years of Life Science/Biotechnology/Pharmacology/Information Systems experience 

• Advanced experience in designing and executing both manual and automated test cases based on functional and non-functional requirements.
• Advanced knowledge of test lifecycle documentation including test plans, RTMs, OQ protocols, and summary reports
• Hands-on experience with UiPath Test Suite, Selenium, Postman, or similar tools.
• Advanced experience in validated (GxP) environments and with CSV practices
• Proficient in creating test lifecycle documentation (RTMs, OQ protocols, test plans, reports) and supporting end-to-end testing within regulated GxP and CSV-compliant computer systems, ensuring adherence to validation, audit, and documentation standards

• Develop, enhance, and maintain test automation scripts using data-driven, keyword-driven, or hybrid frameworks, enabling reusable, scalable, and maintainable test coverage across systems.
• Familiarity with Agile/Scrum methodologies and continuous testing practices
• Strong test design and problem-solving skills.
• Familiarity with Jenkins, GitHub Actions, or similar tools for integrating testing into DevOps pipelines.
• Experience collaborating with Cross-Functional teams, particularly within healthcare or pharmaceutical environments.
• Experience in handling product features for PI planning and developing product roadmaps and user journeys
• Able to communicate complex subject matters in business terms
• Familiarity with GxP, CFR 21 Part 11 and systems validation

• ISTQB Foundation or Advanced Level Certification (Optional but valuable)
• SAFe Agile Tester Certification (Optional but valuable)
• Lean Six Sigma certification (Optional but valuable)
• PMP Certification (Optional but valuable)

• Excellent critical-thinking and problem-solving skills
• Strong communication and collaboration skills
• Demonstrated awareness of how to function in a team setting
• Demonstrated awareness of presentation skills

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.