IT/OT Lab Specialist
Core
Support computerized systems and laboratory technologies to ensure reliable performance, compliance, and operational efficiency in pharmaceutical labs.
Role type
IT/OT Lab Specialist
Builds
Laboratory computerized systems, instrument connectivity, and system architectures
Domain
Pharmaceutical/Biopharmaceutical Laboratory Operations
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Laboratory computerized system installation and configuration, GMP environment experience, Corporate network infrastructure implementation, FDA 21 CFR Part 11 knowledge, Vendor relationship management, System lifecycle management, Change control management, CAPA management, Audit trail review, Troubleshooting in regulated environments
Preferred skills
Quality by Design, Six Sigma, Operational Excellence methodologies, Investigation support, Non-conformance support
Technologies
Python, Automation Testing, Robotics, Debugging, Software Testing, Test Automation
Responsibilities
Support design, installation, configuration, and maintenance of laboratory instruments and software; Ensure high availability of computerized systems; Partner with vendors on system architectures; Execute maintenance and audit trail reviews; Manage change controls and CAPAs; Support FDA inspections and audits; Drive continuous improvement initiatives
Seniority
Mid-Senior, hands-on IC
