GxP Sr. Systems Engineer
Core
Administer, configure, and validate Chromeleon CDS systems for laboratory informatics in a GMP environment.
Role type
Senior GxP Systems Engineer (Laboratory Informatics)
Builds
Validated laboratory information management systems (LIMS/CDS) and instrument integrations
Domain
Biopharmaceutical / GxP / Laboratory Informatics
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
GxP validation methodologies, GAMP 5, 21 CFR Part 11, ALCOA+, change control, IQ/OQ/PQ/UAT, test script development, data integrity controls
Preferred skills
Cloud-hosted system experience, digital laboratory workflows, system upgrade migrations
Technologies
Chromeleon CDS, Chromeleon v7.3.2
Responsibilities
Administer and configure Chromeleon CDS across Quality labs, execute validation activities per approved plans, support system upgrades and version migrations, maintain inspection readiness and audit support, partner with stakeholders for issue resolution and UAT
Seniority
Senior, hands-on IC
