Amgen Inc. is looking for a Specialist IS Analyst to join the team responsible for the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform. In this role, you will drive the design, development, validation, support, and optimization of Amgen Operations' ELN ecosystem within a GxP-regulated environment to accelerate product development and manufacturing.

What You'll Do

Work as part of a Product Team on the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform.
Collaborate with technical product owners, business analysts, test/validation engineers, project managers, and scrum masters.
Conduct software engineering and platform ownership activities, including code reviews and creating/maintaining architecture, design, validation, and operations documentation.
Lead and contribute to enterprise application testing in GxP environments, ensuring compliance with FDA, EMA, and global regulatory requirements.
Own and execute CSV/CSA activities, including risk assessments, test strategy, IQ/OQ/PQ, traceability, and validation documentation.
Develop and maintain test plans, test scenarios, and test scripts for system enhancements, patches, upgrades, and vendor releases.
Perform functional, regression, integration, and user acceptance testing (UAT).
Provide Level 2 / Level 3 application support for ELN and associated enterprise platforms.
Manage incident, problem, and change processes, including P1/P2 incident response and root cause analysis.
Support production releases, vendor upgrades, hotfixes, and patches.
Work within ITIL-based processes using ServiceNow for incident, change, and problem management.
Ensure platform stability, performance monitoring, and operational readiness in regulated environments.
Work closely with product teams, business partners, validation, quality, data scientists, and vendors.
Drive system enhancements, bug fixes, and continuous improvements across the platform landscape.
Develop and implement business process improvements to increase efficiency and effectiveness.
Effectively operate within large, diverse, and globally dispersed teams in a matrixed organization.
Leverage AI and automation to streamline testing, support workflows, and operational processes.

What We're Looking For

Bachelor's OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering.
Strong experience with enterprise application testing in GxP-regulated environments.
Hands-on experience with CSV/CSA validation methodologies and documentation.
Software engineering best practices: Git, CI/CD (Jenkins, Maven), automated testing.
Experience supporting enterprise platforms with issue ticketing and customer-facing support models.
Proven experience in Application Support & Maintenance (AMS) for regulated systems.
Experience with cloud platforms (AWS, Azure, GCP).
Incident response experience, including P1/P2 production incidents.
Experience with ServiceNow, ITIL processes, and change management workflows.
Ability to translate vendor capabilities and constraints into business-aligned solutions.
Scripting and automation for server and operational task automation.
Familiarity with AI tools (ChatGPT, Copilot, etc.) to improve productivity and workflows.

Nice to Have

SAFe for Teams certification (preferred).
Strong customer focus with the ability to partner closely with business stakeholders.
Experience supporting 200+ servers or large-scale enterprise platforms.
Experience with Smartsheets, Excel, Tableau, Spotfire.
Ability to work independently with strong analytical and written communication skills.

Technical Stack

Version Control & CI/CD: Git, Jenkins, Maven
Cloud Platforms: AWS, Azure, GCP
IT Service Management: ServiceNow
Analytics & Productivity: Smartsheets, Excel, Tableau, Spotfire
AI Tools: ChatGPT, Copilot

Team & Environment

You will be part of a matrixed, global organization, working within a globally distributed team that includes technical product owners, business analysts, test/validation engineers, project managers, and scrum masters.

Amgen is an equal opportunity employer.