Career CategoryInformation SystemsJob DescriptionLet’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 OwnershipPossess strong software development skills and rapidly translate concepts into working, production-ready solutionsConduct code reviews to ensure quality, security, performance, and adherence to enterprise standardsCreate and maintain documentation for architecture, design, validation, deployment, disaster recovery, and operationsIdentify, troubleshoot, and resolve complex technical challenges across integrated enterprise platformsStay current with emerging technologies, industry best practices, and regulated system development trendsGxP Testing, Validation & QualityLead and contribute to enterprise application testing in GxP environments, ensuring compliance with FDA, EMA, and global regulatory requirementsOwn and execute CSV/CSA activities, including risk assessments, test strategy, IQ/OQ/PQ (or equivalent), traceability, and validation documentationDevelop and maintain test plans, test scenarios, and test scripts for system enhancements, patches, upgrades, and vendor releasesPerform functional, regression, integration, and user acceptance testing (UAT) to ensure changes do not negatively impact validated functionalityPartner with Quality, Validation, and Business teams to support audits, inspections, and validation lifecycle activitiesApplication Support & Maintenance (AMS)Provide Level 2 / Level 3 application support for ELN and associated enterprise platformsManage incident, problem, and change processes, including P1/P2 incident response and root cause analysisSupport production releases, vendor upgrades, hotfixes, and patches, ensuring minimal disruption to business operationsWork within ITIL-based processes using ServiceNow for incident, change, and problem managementCollaborate with infrastructure, vendor, and business partners to resolve operational bottlenecks and systemic issuesEnsure platform stability, performance monitoring, and operational readiness in regulated environmentsCross-Functional Collaboration & DeliveryWork closely with product teams, business partners, validation, quality, data scientists, and vendorsDrive system enhancements, bug fixes, and continuous improvements across the platform landscapeDevelop and implement business process improvements to increase efficiency and effectivenessEffectively operate within large, diverse, and globally dispersed teams in a matrixed organizationLeverage AI and automation to streamline testing, support workflows, and operational processesBasic QualificationsBachelor's OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning EngineeringFunctional SkillsMust-Have SkillsStrong experience with enterprise application testing in GxP-regulated environmentsHands-on experience with CSV/CSA validation methodologies and documentationSoftware engineering best practices: Git, CI/CD (Jenkins, Maven), automated testingExperience supporting enterprise platforms with issue ticketing and customer-facing support modelsProven experience in Application Support & Maintenance (AMS) for regulated systemsExperience with cloud platforms (AWS, Azure, GCP)Incident response experience, including P1/P2 production incidentsExperience with ServiceNow, ITIL processes, and change management workflowsAbility to translate vendor capabilities and constraints into business-aligned solutionsScripting and automation for server and operational task automationFamiliarity with AI tools (ChatGPT, Copilot, etc.) to improve productivity and workflowsGood-to-Have SkillsStrong customer focus with the ability to partner closely with business stakeholdersExperience supporting 200+ servers or large-scale enterprise platformsExperience with Smartsheets, Excel, Tableau, SpotfireAbility to work independently with strong analytical and written communication skillsProfessional CertificationsSAFe for Teams certification (preferred)Soft SkillsStrong leadership, transformation, and change management capabilitiesAbility to work effectively with global, virtual teamsExcellent analytical, troubleshooting, and decision-making skillsAbility to manage multiple priorities in a fast-paced, regulated environmentStrong presentation, communication, and stakeholder engagement skillsHigh degree of initiative, accountability, and self-motivation.