Sr. Associate Software Engineer at Amigen

Hyderabad, Andhra Pradesh, India -

Full Time

Start Date

Immediate

Expiry Date

03 Feb, 26

Salary

0.0

Posted On

05 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software Development, System Ownership, GxP Compliance, Validation, Data Integrity, SQL, Python, AWS, APIs, Agile Practices, DevOps, Integration, Collaboration, Troubleshooting, Documentation, Continuous Improvement

Industry

Biotechnology Research

Description

Career Category Information Systems Job Description 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 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. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Would you like to take your software engineering skills and help deliver the world's most advanced and life-changing biotech medicines? If you are excited to work on latest and greatest technology stack, we are looking for you. The Associate will work with some of the brightest minds in the industry and get opportunities to solve some of the most challenging business problems. At Amgen, your work will improve the lives of millions of patients around the world. 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 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 (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 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. Basic Qualifications Master's degree OR Bachelor's degree and 2 - 6 years of Information Science experience Preferred Qualifications 2 + years of direct experience with Biovia OneLab ELN, THermo Fisher Sample Manager LIMS or comparable ELN solutions (e.g., Biovia Workbook, LabWare, Labguru). 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 (e.g., LIMS, inventory systems, data warehouses). 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, ensuring alignment between business needs and technical delivery. Thrive Some of the vast rewards of working here As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being. 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com . 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

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Responsibilities

The Senior Associate Software Engineer will design, develop, and maintain secure applications and integrations across various platforms while ensuring compliance with regulatory requirements. They will also manage system lifecycle activities and collaborate with cross-functional teams to deliver validated solutions.