Specialist IS Analyst

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 sel