GxP Sr. Systems Engineer

Moderna

5d • $121,600 - $194,500 • Onsite

About The Position

Moderna is seeking a Sr. Manager who will serve a key role supporting the delivery and administration of laboratory systems. The individual will assist in configuration and deployment of systems, participate in generating and maintaining necessary procedure. Activities will also include authoring and executing test protocols. On-site presence is required with possible travel between regional sites. Additional duties may be assigned from time to time.

Requirements

• 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.

Nice To Haves

• Experience working with cloud-hosted or hybrid digital systems preferred.
• 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.

Responsibilities

• Administer, configure, and maintain Chromeleon CDS across Moderna Quality labs.
• Support the implementation of the Chromeleon v7.3.2 CDS upgrade including participation in infrastructure updates, application deployment activities, and instrument client upgrades.
• Execute validation activities in accordance with approved validation plans, including protocol execution, test script development, traceability support, and documentation compilation.
• Assist with server upgrade validation activities in coordination with Infrastructure and Validation teams.
• Support change control (CC), SOP updates, work instructions, and qualification documentation as required.
• Participate in regression testing and system verification to ensure Chromeleon functionality and instrument integrations perform as intended post-upgrade.
• Ensure data integrity controls (ALCOA+) are maintained during upgrade, configuration, and validation activities.
• Partner with Digital and QC stakeholders to support issue resolution, user acceptance testing (UAT), and post-deployment stabilization.
• Maintain inspection readiness through adherence to internal quality policies, procedures, and training requirements.
• Participate in audit support activities as a subject matter contributor for Chromeleon-related documentation and system controls.
• Apply a continuous improvement mindset to identify opportunities to optimize Chromeleon workflows and system performance.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed