Specialist IS Analyst

<h2><b>Career Category</b></h2>Information Systems<h2></h2><h2><b>Job Description</b></h2><p>Let’s do this. Let’s change the world.</p><p></p><p>In this vital role, you will work as part of a Product Team focusing on the <b>Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform</b>, accelerating Amgen’s product development and commercial manufacturing. You will collaborate with a dynamic, globally distributed team of technical product owners, business analysts, <b>test/validation engineers</b>, project managers, and scrum masters on the <b>design, development, validation, support, and continuous optimization</b> of Amgen Operations’ ELN ecosystem. This role requires <b>strong hands-on experience with enterprise platform and application testing in a GxP-regulated environment</b>, including <b>CSV/CSA activities</b>, to ensure systems meet regulatory, quality, and data integrity standards. In addition, the role demands <b>significant experience in Application Support and Maintenance (AMS)</b>, including incident management, release support, upgrades, patches, and operational stability of mission-critical laboratory platforms. The ideal candidate brings deep expertise in <b>ELN applications, enterprise application integration, end-to-end data and process harmonization</b>, 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 <b>matrixed, global organization</b>, balancing innovation with compliance, operational excellence, and system reliability.</p><p></p><h3>Software Engineering &amp; Platform Ownership</h3><ul><li><p>Possess strong software development skills and rapidly translate concepts into working, production-ready solutions</p></li><li><p>Conduct code reviews to ensure quality, security, performance, and adherence to enterprise standards</p></li><li><p>Create and maintain documentation for <b>architecture, design, validation, deployment, disaster recovery, and operations</b></p></li><li><p>Identify, troubleshoot, and resolve complex technical challenges across integrated enterprise platforms</p></li><li><p>Stay current with emerging technologies, industry best practices, and regulated system development trends</p></li></ul><p></p><h3>GxP Testing, Validation &amp; Quality</h3><ul><li><p><b>Lead and contribute to enterprise application testing in GxP environments</b>, ensuring compliance with FDA, EMA, and global regulatory requirements</p></li><li><p>Own and execute <b>CSV/CSA activities</b>, including risk assessments, test strategy, IQ/OQ/PQ (or equivalent), traceability, and validation documentation</p></li><li><p>Develop and maintain <b>test plans, test scenarios, and test scripts</b> for system enhancements, patches, upgrades, and vendor releases</p></li><li><p>Perform <b>functional, regression, integration, and user acceptance testing (UAT)</b> to ensure changes do not negatively impact validated functionality</p></li><li><p>Partner with Quality, Validation, and Business teams to support audits, inspections, and validation lifecycle activities</p></li></ul><p></p><h3>Application Support &amp; Maintenance (AMS)</h3><ul><li><p>Provide <b>Level 2 / Level 3 application support</b> for ELN and associated enterprise platforms</p></li><li><p>Manage <b>incident, problem, and change processes</b>, including P1/P2 incident response and root cause analysis</p></li><li><p>Support <b>production releases, vendor upgrades, hotfixes, and patches</b>, ensuring minimal disruption to business operations</p></li><li><p>Work within <b>ITIL-based processes</b> using ServiceNow for incident, change, and problem management</p></li><li><p>Collaborate with infrastructure, vendor, and business partners to resolve operational bottlenecks and systemic issues</p></li><li><p>Ensure platform stability, performance monitoring, and operational readiness in regulated environments</p></li></ul><p></p><h3>Cross-Functional Collaboration &amp; Delivery</h3><ul><li><p>Work closely with product teams, business partners, validation, quality, data scientists, and vendors</p></li><li><p>Drive system enhancements, bug fixes, and continuous improvements across the platform landscape</p></li><li><p>Develop and implement business process improvements to increase efficiency and effectiveness</p></li><li><p>Effectively operate within large, diverse, and globally dispersed teams in a matrixed organization</p></li><li><p>Leverage <b>AI and automation</b> to streamline testing, support workflows, and operational processes</p></li></ul><p></p><h2>Basic Qualifications</h2><ul><li><p>Bachelor&#39;s OR Master’s degree with 8–12 years of experience in Software Engineering, Data Science, or Machine Learning Engineering</p></li></ul><h2></h2><h2>Functional Skills</h2><h3></h3><h3>Must-Have Skills</h3><ul><li><p>Strong experience with <b>enterprise application testing in GxP-regulated environments</b></p></li><li><p>Hands-on experience with <b>CSV/CSA validation methodologies and documentation</b></p></li><li><p>Software engineering best practices: Git, CI/CD (Jenkins, Maven), automated testing</p></li><li><p>Experience supporting <b>enterprise platforms with issue ticketing and customer-facing support models</b></p></li><li><p>Proven experience in <b>Application Support &amp; Maintenance (AMS)</b> for regulated systems</p></li><li><p>Experience with cloud platforms (AWS, Azure, GCP)</p></li><li><p>Incident response experience, including <b>P1/P2 production incidents</b></p></li><li><p>Experience with <b>ServiceNow, ITIL processes, and change management workflows</b></p></li><li><p>Ability to translate vendor capabilities and constraints into business-aligned solutions</p></li><li><p>Scripting and automation for server and operational task automation</p></li><li><p>Familiarity with AI tools (ChatGPT, Copilot, etc.) to improve productivity and workflows</p></li></ul><p></p><h3>Good-to-Have Skills</h3><ul><li><p>Strong customer focus with the ability to partner closely with business stakeholders</p></li><li>Experience supporting <b>200&#43; servers</b> or large-scale enterprise platforms</li><li><p>Experience with Smartsheets, Excel, Tableau, Spotfire</p></li><li><p>Ability to work independently with strong analytical and written communication skills</p></li><li></li></ul><p></p><h2>Professional Certifications</h2><ul><li><p>SAFe for Teams certification (preferred)</p></li></ul><p></p><h2>Soft Skills</h2><ul><li><p>Strong leadership, transformation, and change management capabilities</p></li><li><p>Ability to work effectively with global, virtual teams</p></li><li><p>Excellent analytical, troubleshooting, and decision-making skills</p></li><li><p>Ability to manage multiple priorities in a fast-paced, regulated environment</p></li><li><p>Strong presentation, communication, and stakeholder engagement skills</p></li><li><p>High degree of initiative, accountability, and self-motivation</p></li></ul><p></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.