Senior Systems Engineer, GXP Systems
Core
Design, deploy, and manage benchtop instrumentation and enterprise laboratory systems (CDS, SDMS, LIMS) to create a unified, compliant digital lab environment for Quality Control.
Role type
Senior Systems Engineer (GXP/Life Sciences)
Builds
Scalable, compliant digital lab solutions integrating hardware, software, and data pipelines for vaccine production.
Domain
Biopharmaceutical manufacturing / GxP compliance / Laboratory automation
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Life sciences enterprise systems design, GAMP/GxP compliance, instrument integration, data integrity regulations, cloud/on-prem connectivity, change control, regulatory documentation, process improvement, hands-on engineering, audit readiness
Preferred skills
Automation solutions (Hamilton Venus), Generative AI integration, cross-functional collaboration, independent decision making
Technologies
Thermo Omnic FTIR, HIAC Particle Counter, TOC, Thermo QuantStudio/3730, RAMAN TruScan, Chromeleon CDS, LogiLab SDMS, CFR Gateway, SoftMax Pro, MODA, Labvantage LIMS/LES, Hamilton Venus, Cloud/SAAS
Responsibilities
Design and deploy instrumentation portfolios, own full product lifecycle management, translate system requirements into compliant implementations, lead change control and regulatory documentation, validate system integration for robotics/AI, implement process improvements, serve as subject matter expert for audits, define new processes
Seniority
Senior, hands-on IC
