2 of 2 21 CFR Part 11 Jobs in the Thames Valley

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 ❯

this role, you will collaborate closely with Quality teams, IT functions, and implementation partners to ensure seamless solution delivery, system integration, and regulatory compliance. You’ll play a key part in bridging the gap between business needs and technical execution within a GxP-regulated environment. Key Responsibilities: Collaborate with site quality teams to gather and analyse business requirements. Configure … solution delivery and alignment with Biovia platform capabilities . Set up and manage integrations with enterprise systems such as LIMS, ELN, ERP, and MES . Ensure compliance with 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 More ❯