GxP Sr. Systems Engineer (Chromeleon CDS)

Location: Remote - US; on-site presence is required, with possible travel between regional sites. Only U.S. persons are eligible.

Salary: $121,600–$194,500 annually; California range: $144,150–$165,850. Additional bonus, incentive compensation, or equity may be available.

Company

hirify.global is a biotechnology company developing mRNA technology and medicines.

What you will do

• Administer, configure, and maintain Chromeleon CDS across quality laboratories.
• Support the Chromeleon v7.3.2 upgrade, including infrastructure updates, application deployment, and instrument client upgrades.
• Execute validation activities, develop test scripts and protocols, support traceability, and compile qualification documentation.
• Perform regression testing and system verification for Chromeleon functionality and instrument integrations.
• Maintain change controls, SOPs, work instructions, data integrity controls, and inspection readiness.
• Collaborate with Digital, QC, Infrastructure, and Validation teams on issue resolution, UAT, audits, and post-deployment stabilization.

Requirements

• 10 years of experience implementing or validating laboratory informatics systems such as SDMS, LIMS, ELN, or CDS in 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 with change control and IQ/OQ/PQ/UAT qualification documentation.
• Understanding of laboratory instrument integration and digital laboratory workflows.
• Ability to work on site as required, travel between regional sites, and qualify as a U.S. person under U.S. export control requirements.

Nice to have

• Experience with cloud-hosted or hybrid digital systems.
• Strong documentation rigor, attention to detail, and ability to manage concurrent validation activities.
• Experience collaborating across Digital, QC, Infrastructure, and Validation teams in a matrix environment.

Culture & Benefits

• 70/30 work model emphasizing in-office collaboration and mentorship.
• Healthcare and voluntary benefits, wellness resources, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid time off, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investment programs, plus location-specific benefits.