Specialist IS Analyst

Job description

Career Category Information Systems

Job Description

Let’s do this. Let’s change the world. In this vital role, you will work as part of a Product Team focusing on the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform , accelerating Amgen’s product development and commercial manufacturing. You will collaborate with a dynamic, globally distributed team of technical product owners, business analysts, test/validation engineers , project managers, and scrum masters on the design, development, validation, support, and continuous optimization of Amgen Operations’ ELN ecosystem.

This role requires strong hands-on experience with enterprise platform and application testing in a GxP-regulated environment , including CSV/CSA activities , to ensure systems meet regulatory, quality, and data integrity standards. In addition, the role demands significant experience in Application Support and Maintenance (AMS) , including incident management, release support, upgrades, patches, and operational stability of mission-critical laboratory platforms.

The ideal candidate brings deep expertise in ELN applications, enterprise application integration, end-to-end data and process harmonization , and the seamless integration of laboratory instrument data with enterprise systems (e.g., LIMS, CDS, MES, data platforms). Success in this role requires comfort working in a matrixed, global organization , balancing innovation with compliance, operational excellence, and system reliability.

Software Engineering & Platform Ownership Possess strong software development skills and rapidly translate concepts into working, production-ready solutions

• Conduct code reviews to ensure quality, security, performance, and adherence to enterprise standards
• Create and maintain documentation for architecture, design, validation, deployment, disaster recovery, and operations
• Identify, troubleshoot, and resolve complex technical challenges across integrated enterprise platforms
• Stay current with emerging technologies, industry best practices, and regulated system development trends GxP Testing, Validation & Quality
• 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 (or equivalent), 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) to ensure changes do not negatively impact validated functionality
• Partner with Quality, Validation, and Business teams to support audits, inspections, and validation lifecycle activities Application Support & Maintenance (AMS) 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 , ensuring minimal disruption to business operations
• Work within ITIL-based processes using ServiceNow for incident, change, and problem management
• Collaborate with infrastructure, vendor, and business partners to resolve operational bottlenecks and systemic issues
• Ensure platform stability, performance monitoring, and operational readiness in regulated environments

Cross-Functional Collaboration & Delivery

• 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

Basic Qualifications

• Bachelor's OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering Functional Skills Must-Have Skills
• 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

Good-to-Have Skills

• 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 Professional Certifications SAFe for Teams certification (preferred) Soft Skills
• Strong leadership, transformation, and change management capabilities
• Ability to work effectively with global, virtual teams
• Excellent analytical, troubleshooting, and decision-making skills
• Ability to manage multiple priorities in a fast-paced, regulated environment
• Strong presentation, communication, and stakeholder engagement skills High degree of initiative, accountability, and self-motivation .