Labs and Manufacturing IT Lead
Core
Provide on-site technical support, monitor critical production systems, and maintain inventory for Manufacturing and R&D environments in compliance with GxP and regulatory standards.
Role type
Senior IT Operations Lead (Manufacturing & R&D)
Builds
Validated applications and critical production systems for medical device manufacturing and R&D operations
Domain
MedTech / Pharmaceuticals / Manufacturing IT
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
IT application support, troubleshooting software issues, incident management, regulatory compliance (GxP, FDA, EMA), vendor coordination, project management, documentation, metrics reporting, change control processes
Preferred skills
ITIL certification, BRMP certification, experience with MES/LIMS systems, knowledge of FDA 21 CFR Part 11, experience in MedTech or Pharmaceuticals
Technologies
Industrial PCs, ruggedized devices, machinery interfaces, validated applications, MES, LIMS
Responsibilities
Provide on-site technical support for validated applications in critical manufacturing processes; monitor critical manufacturing production systems and applications; troubleshoot equipment failures on the factory floor; coordinate vendor relationships for specialized systems; support incident management for P1 & P2 incidents impacting manufacturing operations; create and maintain documentation for factory-specific IT support and incident resolution.
Seniority
Senior, hands-on IC with leadership responsibilities
