Software Development Engineer

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. Youll 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 Amgens 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

Masters 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.