2 of 2 21 CFR Part 11 Jobs in the South East

people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And thats the kind of work we want to be part of. The role: The role of a Laboratory Systems Specialist is to lead the development and implementation of robust Lab/digital infrastructure within our R&D laboratories for … network connectivity (e.g., OPC-UA, MQTT, REST APIs, TCP/IP) and data pipelines from edge devices to cloud/on-premise environments. Support system validation efforts (e.g., CSV, 21 CFR Part 11 compliance) in partnership with QA and IT Compliance teams, while also providing technical troubleshooting and support for instrument connectivity and data integration issues. … UA, MQTT, REST/SOAP APIs, SQL, Python, etc. Familiarity with lab automation platforms (e.g., Tecan, Hamilton, Agilent, Beckman, Sartorius) and related data workflows. A good understanding of GxP, 21 CFR Part 11, data integrity principles, and validated environments is a plus. Every day, Lonzas products and services have a positive impact on millions of people. More ❯

and alignment with platform capabilities. Set up and manage integrations between OneLab and other enterprise systems (e.g., LIMS, ELN, ERP, MES). Ensure compliance with regulatory standards including GxP, 21 CFR Part 11, and internal validation protocols. Troubleshoot and resolve configuration and integration issues. Document configuration and integration processes for validation and audit readiness. Provide training More ❯