Software Development Engineer-test Ii

Career Category Information Systems 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 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 ABOUT THE ROLE Role Description The Software Development Engineer-Test position offers a unique opportunity to join a fun innovative engineering team within the AI Data Science AI D - Enterprise Automation organization You ll work on next-generation capabilities and services in Applied AI Automation using innovative COTS products open-source software frameworks tools and cloud computing services The role also emphasizes demonstrating these capabilities to support critical business operations and initiatives in ensuring quality compliance and performance across Amgen s Applied AI Automation Footprint In this role you will be responsible for ensuring the quality and compliance of enterprise automation solutions platforms 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 out test engineering practices standards community and lead by execution in creating a new culture around the test automation demeanor Design develop and maintain automated and manual test cases based on functional and non-functional requirements Perform responsibilities in compliance with GxP and Computer System Validation CSV regulations ensuring proper documentation execution and adherence to regulatory standards Create and maintain the Requirement Traceability Matrix RTM to ensure full test coverage Log track and manage defects using tools such as HP ALM or JIRA ensuring clear documentation and traceability Assist in User Acceptance Testing UAT working closely with business stakeholders Execute tests including Systems Integration Testing SIT Operational Qualification OQ and regression testing Execute test scripts provided by analysts focusing on accuracy and completeness of testing Collaborate with developers to ensure all identified bugs and issues are addressed and resolved effectively Support automation testing efforts by building and maintaining scripts in tools like UiPath Test Suite Selenium or similar tools Maintain detailed documentation of test cycles supporting audit readiness and compliance Basic Qualifications Master s degree and 5 to 9 years of Life Science Biotechnology Pharmacology Information Systems experience Preferred Qualifications BS MS in Computer Science Information Systems or related field 5 years of experience in application testing and automation frameworks 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 Certified CSV Validation Professional Optional but valuable SAFe Agile Tester 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 We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment Please contact us to request accommodation