GxP Sr. Systems Engineer
$121,600–$194,500 year
RemoteUnited States
Job Summary
Administer, configure, and maintain Chromeleon CDS across Moderna Quality labs while supporting the implementation of the v7.3.2 upgrade, including infrastructure updates, application deployment, and instrument client upgrades. Execute validation activities per approved plans, develop test scripts, and ensure data integrity controls (ALCOA+) are maintained throughout configuration and validation. Partner with Digital, QC, and Infrastructure teams for issue resolution, user acceptance testing, and post-deployment stabilization. Assist with server upgrade validation, change control, SOP updates, and audit support as a subject matter contributor. Maintain inspection readiness through adherence to internal quality policies and training requirements. On-site presence is required with possible travel between regional sites.
Required Qualifications
- 10 years' experience supporting implementation or validation of laboratory informatics systems (SDMS, LIMS, ELN, CDS) within a biopharmaceutical GMP environment
- Experience with GxP validation methodologies including GAMP 5, 21 CFR Part 11, Annex 11, and data integrity regulations
- Experience supporting system upgrades or version migrations in regulated environments
- Experience contributing to change control and qualification documentation (IQ/OQ/PQ/UAT)
- Understanding of laboratory instrument integration and digital laboratory workflows
- On-site presence
- possible travel between regional sites
- ability to access export-controlled information in accordance with U.S. law
- qualification as a U.S. person (citizens, permanent residents, asylees, or refugees)
Desired Qualifications
- Experience working with cloud-hosted or hybrid digital systems
- Strong attention to detail and documentation rigor
- Ability to execute validation activities within defined timelines and governance structures
- Foundational understanding of laboratory data management systems and instrument connectivity
- Strong interpersonal skills with the ability to collaborate effectively across Digital, QC, Infrastructure, and Validation teams
- Ability to manage multiple concurrent tasks in a fast-paced GMP environment
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
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