Specialist IS Analyst

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