Senior GxP Lab Informatics Systems Engineer

Moderna Therapeutics; United States; Remote; USD 122,000 - 195,000; Full time

Benefits offered by this job

Health benefits

Well-being programs

Family planning benefits

Generous PTO

Savings plans

Location perks

Job summary

Moderna is seeking a Sr. Manager to lead the delivery and administration of Chromeleon CDS across Quality labs, configuring, deploying, and validating systems while authoring test protocols and ensuring data integrity.

You will coordinate with Digital, QC, Infrastructure, and Validation teams, support audits, and maintain inspection readiness, with on-site work and occasional travel between regional sites.

Qualifications

• Extensive experience validating laboratory informatics systems in GMP environments.
• Knowledge of GxP validation, 21 CFR Part 11, and data integrity.
• Experience upgrading and validating laboratory information systems.
• Ability to author and execute validation test protocols and IQ/OQ/PQ/UAT.
• Proven collaboration across Digital, QC, Infrastructure, and Validation teams.

Responsibilities

• Administer, configure, and maintain Chromeleon CDS across Quality labs.
• Support CDS upgrades and instrument client upgrades with validation.
• Develop and execute test scripts, maintain traceability and documentation.
• Assist with server upgrade validation and change control documentation.
• Coordinate with stakeholders for UAT, audits, and post‑deployment validation.
• Ensure ALCOA+ data integrity during upgrade, configuration, and validation.

Skills

Attention to detail

Project management

GxP knowledge

System validation

Team collaboration

Tools

Chromeleon CDS

LIMS

SDMS/ELN CDS family

Job description

Moderna is seeking a Sr. Manager to lead the delivery and administration of Chromeleon CDS across Quality labs, configuring, deploying, and validating systems while authoring test protocols and ensuring data integrity.

You will coordinate with Digital, QC, Infrastructure, and Validation teams, support audits, and maintain inspection readiness, with on-site work and occasional travel between regional sites.