Specialist IS Analyst

Amgen Inc. (IR); Hyderabad; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Amgen Inc. (IR) is seeking a product/platform owner for the ELN ecosystem, focusing on testing, validation, and AMS in a regulated environment. The role involves enterprise platform integration, data harmonization, and ensuring data integrity across LIMS, CDS, MES, and data platforms.

You will work with a global team to drive risk-based validation, release support, and continuous improvements while balancing innovation with regulatory compliance.

Qualifications

• 8–12 years of experience in Software Engineering, Data Science, or ML engineering in regulated environments.
• Hands-on enterprise application testing in GxP environments with CSV/CSA validation.
• Experience with cloud platforms and incident/change management (ITIL).
• Ability to work in matrixed, global teams and translate vendor capabilities into solutions.
• Proficient scripting and automation for server tasks.

Responsibilities

• Lead enterprise ELN testing, validation, and AMS activities.
• Own CSV/CSA validation and test strategy, including traceability and documentation.
• Collaborate with QA, validation, and business teams for audits and lifecycle activities.
• Support deployments, patches, vendor upgrades, and incident resolution.
• Drive cross-functional improvements across the platform landscape.

Skills

GxP testing

CSV/CSA validation

CI/CD (Git, Jenkins, Maven)

ITIL / ServiceNow

AMS for regulated systems

Cloud platforms (AWS/Azure/GCP)

Automation scripting

Education

Bachelor's or Master's in Software Engineering/Data Science/ML

Tools

Git

Jenkins

Maven

ServiceNow

Tableau

Smartsheets

Excel

Spotfire

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

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen