Software Development Engineer- Test II

Role Description:

The Software Development Engineer-Test II position offers a unique opportunity to join a fun, innovative engineering team within the AI & Data Science (AI&D) - organization. We are the Applied AI team (AI Studio). AI Studio is Amgen’s enterprise engine for turning high-value business challenges into scalable AI products. We partner with key business partners across the company to identify the right opportunities, shape them into actionable use cases, and design, build, and launch AI products responsibly. Our work spans the full lifecycle—from early discovery and rapid prototyping to production deployment, reuse across the enterprise, and measurable business impact.

In this role, you will be responsible for ensuring the quality and compliance of enterprise automation solutions with a strong focus on computer systems validation including test automation, test planning, execution, and defect management. You will work closely with product owners, developers, and QA teams to validate systems against business and regulatory requirements. This role is critical in ensuring that automation solutions meet performance, security, and compliance expectations across the development lifecycle, especially in GxP-regulated environments.

Roles & Responsibilities:

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.

Basic Qualifications

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

Functional Skills:

Must-Have Skills:

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

Good-to-Have Skills:

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

Professional Certifications

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)

Soft Skills:

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

EQUAL OPPORTUNITY STATEMENT

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.