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Amgen Logo Amgen · IT - Software Development

Specialist Software Development

India, Hyderabad · Job Posted January 16, 2026
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Job Description

As a Specialist at Amgen, you will be responsible for developing and maintaining software applications to meet business needs. You will collaborate with a team of software engineers, participate in the full software development life cycle, and ensure the delivery of high-quality code and solutions. Your strong programming skills, problem-solving abilities, and attention to detail will contribute to the development of robust and scalable software solutions.

Job Responsibility

  • Design, develop, and maintain secure, scalable applications and integrations across QC and commercial platforms (AWS, Databricks, Salesforce Marketing Cloud, Mulesoft, LIMS, ELN, and CDS)
  • Serve as a system owner by managing lifecycle activities (configuration, validation, upgrades, change control, documentation, and audit readiness) in compliance with GxP and 21 CFR Part 11 requirements
  • Collaborate with business analysts, developers, and stakeholders to gather requirements, deliver validated solutions, and support Agile/DevOps practices
  • Champion continuous improvement by troubleshooting issues, optimizing workflows, and evaluating new platform capabilities to enhance business value and user experience
  • Serve as the System Owner for Quality Control Laboratory Platforms (Sample Manager LIMS, Biovia OneLab ELN) ensuring the platform is compliant, validated, secure, and aligned with regulatory requirements
  • Own the system lifecycle — oversee implementation, upgrades, validation, and retirement activities, following Amgen’s system development life cycle (SDLC) and change management processes
  • Act as the primary liaison between product team, support team and client facing technology leads
  • Collaborate closely with developers and technical teams to design, configure, integrate, and validate enhancements, extensions, and interfaces
  • Lead and coordinate validation activities, including authoring/reviewing test scripts, managing traceability matrices, and supporting audit readiness
  • Manage integrations and data workflows between OneLab ELN and supporting systems, ensuring seamless interoperability and secure data exchange
  • Maintain system documentation including requirements, design, SOPs, training materials, validation documents, and user guides
  • Monitor vendor product roadmaps for Biovia OneLab ELN and evaluate applicability to Amgen’s business needs
  • drive adoption of new features when beneficial
  • Ensure audit readiness by maintaining compliant system records, addressing deviations/incidents, and supporting regulatory inspections
  • Champion best practices and innovation in digital lab solutions, helping to modernize workflows while maintaining compliance and quality standards
  • Contribute to Agile ceremonies (standups, sprint planning, retrospectives) and support DevOps/CI/CD activities as applicable

Requirements

  • Master's degree
  • OR Bachelor's degree and 8 - 12 years of Information Science experience
  • 7+ years of direct experience with Biovia OneLab ELN, Thermo Fisher Sample Manager LIMS or comparable ELN solutions
  • Strong understanding of system ownership responsibilities including: GxP compliance, 21 CFR Part 11 requirements, and validation
  • System lifecycle management, change control, and audit readiness
  • Ensuring data integrity and security of scientific records
  • Proven experience integrating and validating systems within a regulated environment (GxP, FDA, EMA)
  • Experience with integrating OneLab ELN, LIMS into broader Operations, R&D and IT ecosystems
  • Familiarity with scientific workflows (biologics, chemistry, lab processes) and ability to translate them into digital solutions
  • Hands-on technical skills with SQL, Python, AWS, and APIs for data workflows, automation, and system integration
  • Knowledge of DevOps/Agile practices, release management, and vendor management for SaaS/enterprise platforms
  • Strong communication skills with the ability to define, document, and understand customer requirements

What we offer

  • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
  • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor
Amgen - All Job Offers

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