8 of 8 21 CFR Part 11 Jobs in England

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 ❯

software products. You'll be responsible for aligning information security and data protection with our mission to deliver FDA-regulated digital therapeutics. This includes leading regulatory security compliance (HIPAA, 21 CFR Part 11, FDA SaMD guidelines), proactively managing risk, and collaborating across engineering, product, compliance, and leadership teams. Location NYC, London, Ramat-Gan This role is … the opportunity to collaborate closely with our dynamic team in person. Responsibilities Design, implement, and lead Remepy's security practice and enterprise cybersecurity program Own security compliance with HIPAA, 21 CFR Part 11, FDA pre/postmarket cybersecurity guidance, and related frameworks Collaborate with Product, Engineering, and Compliance to embed security-by-design across our software More ❯

will follow. Your impact: Design and develop HMI software for bespoke automation systems Integrate HMIs with PLCs, SCADA, MES using OPC UA, Profinet, EtherCAT Ensure compliance with GAMP5, FDA 21 CFR Part 11, EU Annex 11 Drive standardisation across libraries, templates, and processes What you ll bring: 3 years in HMI/SCADA development Strong More ❯

technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We 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 ❯

for capital projects of significant scope and complexity. 2. Provide understanding of project life cycles. 3. Responsible for industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. 4. Development of detailed specification, engineering documents, SOP and operating standards. 5. Ownership and administration of process control automation in a … system automation background focused specifically in design, installation, programming and validation of automated processes. 3. 2+ years combined experience with the following product platforms: Emerson DeltaV DCS systems version 11 or above, Rockwell Automation Factory Talk & ControlLogix PLC Platform. 4. Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering More ❯

for capital projects of significant scope and complexity. 2. Provide understanding of project life cycles. 3. Responsible for industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. 4. Development of detailed specification, engineering documents, SOP and operating standards. 5. Ownership and administration of process control automation in a … system automation background focused specifically in design, installation, programming and validation of automated processes. 3. 2+ years combined experience with the following product platforms: Emerson DeltaV DCS systems version 11 or above, Rockwell Automation Factory Talk & ControlLogix PLC Platform. 4. Ability to create, update and read electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering More ❯

Controls Engineer Bespoke Automation Location: Warwick Hybrid (1 day WFH) Up to £60K Bonus Dividend You didn t become a Controls Engineer to patch tired systems. Here, you ll design and deliver automation that doesn t exist yet.This isn t More ❯