Specialist IS Analyst
Full Job Description
Join Amgen in Hyderabad as a Specialist IS Analyst, a pivotal role within our Product Team focused on the Electronic Lab Notebook (ELN) and Instrument Data Acquisition Platform. You will be instrumental in accelerating Amgen's product development and commercial manufacturing processes. This position involves close collaboration with a diverse, globally distributed team, including technical product owners, business analysts, test/validation engineers, project managers, and scrum masters. Your responsibilities will span the design, development, validation, support, and continuous optimization of Amgen Operations' ELN ecosystem.
This role demands robust hands-on experience in enterprise platform and application testing within a GxP-regulated environment. You will be actively involved in Computerized System Validation (CSV) and Computerized System Assurance (CSA) activities, ensuring our systems meet stringent regulatory, quality, and data integrity standards. Furthermore, significant experience in Application Support and Maintenance (AMS) is crucial, encompassing incident management, release support, upgrades, patches, and maintaining the operational stability of critical laboratory platforms.
The ideal candidate possesses deep expertise in ELN applications, enterprise application integration, and end-to-end data and process harmonization. Seamless integration of laboratory instrument data with enterprise systems such as LIMS, CDS, MES, and data platforms is a key requirement. Success in this dynamic, matrixed, and global organization hinges on balancing innovation with compliance, operational excellence, and unwavering system reliability.
Software Engineering Platform Ownership
- Translate concepts into production-ready solutions, demonstrating strong software development skills.
- Ensure quality, security, performance, and adherence to enterprise standards through code reviews.
- Create and maintain comprehensive documentation for architecture, design, validation, deployment, disaster recovery, and operations.
- Diagnose and resolve complex technical challenges across integrated enterprise platforms.
- Stay abreast of emerging technologies, industry best practices, and trends in regulated system development.
GxP Testing, Validation & Quality
- Lead and contribute to enterprise application testing in GxP environments, ensuring compliance with FDA, EMA, and global regulatory standards.
- Own and execute CSV/CSA activities, including risk assessments, test strategy, IQ/OQ/PQ, traceability, and validation documentation.
- Develop and maintain test plans, scenarios, and scripts for system enhancements, patches, upgrades, and vendor releases.
- Perform functional, regression, integration, and user acceptance testing (UAT) to safeguard validated functionality.
- Collaborate with Quality, Validation, and Business teams to support audits, inspections, and the validation lifecycle.
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 with minimal business disruption.
- Operate within ITIL-based processes using ServiceNow for incident, change, and problem management.
- Partner with infrastructure, vendor, and business teams to resolve operational bottlenecks and systemic issues.
- Ensure platform stability, performance monitoring, and operational readiness in regulated environments.
Cross-Functional Collaboration & Delivery
- Engage 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 enhance efficiency and effectiveness.
- Operate effectively 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
- Extensive experience with enterprise application testing in GxP-regulated environments.
- Hands-on experience with CSV/CSA validation methodologies and documentation.
- Proficiency in 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.
- Familiarity 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.) for productivity enhancement.
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.
- Familiarity 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.
- Capacity 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.
Company
Amgen Inc
Amgen Inc. is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. Our work focuses on areas of high unmet medical ...