Quality Systems Engineer Laboratory Systems
Core
Bridge between business needs and technology solutions for global QC Lab systems, specifically managing projects for Laboratory Instrument connectivity (Empower, Chromeleon) and end-to-end solution engineering.
Role type
Senior IC Quality Systems Engineer (Laboratory Systems)
Builds
End-to-end solutions for chromatography instrumentation and lab workflows (Environmental Monitoring, Raw Materials, QC testing, stability testing)
Domain
Pharmaceutical Quality Control / Laboratory Information Management Systems (LIMS)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Chromatography systems administration (Empower, Chromeleon), GxP/CSV validation (21 CFR Part 11, EU Annex 11), Technical troubleshooting (Windows, DCOM, Active Directory, firewalls), Requirements analysis, Project management, Vendor solution assessment
Preferred skills
MicroFocus ALM, ServiceNow, Waters/Thermo vendor experience, Change Management
Technologies
Chromeleon, Empower, Windows OS, DCOM, Active Directory, ServiceNow, MicroFocus ALM
Responsibilities
Analyze and transform business requirements into technical solutions for lab systems; Oversee architectural design, development, customization, and integration of lab systems; Manage incidents, problems, and root cause analysis for lab-critical systems; Plan and monitor business analysis activities including stakeholder and risk management; Provide oversight of vendor-provided solutions and handle ad-hoc technical requests
Seniority
Senior, hands-on IC with limited supervision
