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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