Senior GxP Systems Engineer: Chromeleon & Validation

BioSpace; United States; On-site; USD 122,000 - 195,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being programs

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna seeks a Senior Manager to lead the delivery and administration of Chromeleon CDS across Quality labs. You will configure, deploy, and validate systems, author test protocols, and ensure data integrity while coordinating with Infrastructure and QC teams.

Role includes on-site work with potential travel, supporting audits, change control, and continuous improvement of Chromeleon workflows within a GMP biopharma setting.

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

Responsibilities

• Administer, configure, and maintain Chromeleon CDS across Moderna Quality labs.
• Support the implementation of the Chromeleon v7.3.2 CDS upgrade including infrastructure updates and instrument client upgrades.
• Execute validation activities in accordance with validated plans, including protocol execution and documentation.
• Assist with server upgrade validation activities in coordination with Infrastructure and Validation teams.
• Support change control, SOP updates, work instructions, and qualification documentation as required.
• Participate in regression testing and system verification 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, UAT, and post-deployment stabilization.
• Maintain inspection readiness through adherence to quality policies and training requirements.
• Participate in audit support for Chromeleon-related documentation and system controls.
• Identify opportunities to optimize Chromeleon workflows and system performance.
• On-site presence is required with possible travel between regional sites.

Skills

Chromeleon CDS

GxP validation

Laboratory informatics

Change control

Validation documentation

Cloud/hybrid systems

Tools

Chromeleon CDS

Job description

Moderna seeks a Senior Manager to lead the delivery and administration of Chromeleon CDS across Quality labs. You will configure, deploy, and validate systems, author test protocols, and ensure data integrity while coordinating with Infrastructure and QC teams.

Role includes on-site work with potential travel, supporting audits, change control, and continuous improvement of Chromeleon workflows within a GMP biopharma setting.