Sr. Associate Software Engineer

As a Senior Associate Software Engineer 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.

Responsibilities

• Design, develop, and maintainsecure, scalable applications and integrations across QC and commercial platforms (AWS, Databricks, Salesforce Marketing Cloud, Mulesoft, LIMS, ELN, and CDS).
• Serve as a system ownerby 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 stakeholdersto gather requirements, deliver validated solutions, and support Agile/DevOps practices.
• Champion continuous improvementby troubleshooting issues, optimizing workflows, and evaluating new platform capabilities to enhance business value and user experience.

Responsibilities

• 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 (e.g., GxP, 21 CFR Part 11, data integrity standards).
• Own the system lifecycle oversee implementation, upgrades, validation, and retirement activities, following Amgens system development life cycle (SDLC) and change management processes.
• Act as the primary liaisonbetween product team, support team and client facing technology leads.
• Collaborate closely with developers and technical teamsto design, configure, integrate, and validate enhancements, extensions, and interfaces (e.g., to LIMS, data lakes, or other lab systems).
• Lead and coordinate validation activities, including authoring/reviewing test scripts, managing traceability matrices, and supporting audit readiness.
• Manage integrations and data workflowsbetween OneLab ELN and supporting systems, ensuring seamless interoperability and secure data exchange.
• Maintain system documentationincluding requirements, design, SOPs, training materials, validation documents, and user guides.
• Monitor vendor product roadmapsfor Biovia OneLab ELN and evaluate applicability to Amgens business needs; drive adoption of new features when beneficial.
• Ensure audit readinessby maintaining compliant system records, addressing deviations/incidents, and supporting regulatory inspections.
• Champion best practices and innovationin 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.

Basic Qualifications

Master's degree

OR

Bachelor's degree and 2 - 6 years of Information Science experience

Preferred Qualifications

• 2 + years of direct experience withBiovia OneLab ELN, THermo Fisher Sample Manager LIMSor comparable ELN solutions (e.g., Biovia Workbook, LabWare, Labguru).
• Strong understanding ofsystem ownership responsibilitiesincluding:
• GxP compliance,21 CFR Part 11requirements, and validation
• System lifecycle management, change control, and audit readiness
• Ensuring data integrity and security of scientific records
• Proven experience integrating and validating systemswithin a regulated environment (GxP, FDA, EMA).
• Experience withintegrating OneLab ELN, LIMSinto broader Operations,R&D and IT ecosystems (e.g., LIMS, inventory systems, data warehouses).
• Familiarity withscientific workflows(biologics, chemistry, lab processes) and ability to translate them into digital solutions.
• Hands-on technical skills withSQL, Python, AWS, and APIsfor data workflows, automation, and system integration.
• Knowledge ofDevOps/Agile practices, release management, and vendor management for SaaS/enterprise platforms.
• Strong communication skills with the ability to define, document, and understand customer requirements, ensuring alignment between business needs and technical delivery.