11 of 11 21 CFR Part 11 Jobs in the UK

In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's 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, Lonza's products and services have a positive impact on millions of 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 ❯

and commercial off-the-shelf (COTS) systems used throughout our pharmaceutical operations. This role is essential to ensuring compliance with GAMP 5 guidelines and global regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), while also supporting a company-wide risk stratification initiative for all GxP-relevant systems. As a CSV Specialist your … areas (e.g., manufacturing, quality control, clinical operations). Excellent written documentation, communication, business process analysis and stakeholder engagement skills. Why Join Us? Joining the Target Healthcare Group means being part of an inspired, enthusiastic team committed to our vision and values. We believe in cultivating a nurturing, dynamic workplace culture. Career Progression and professional development opportunities Flexible Shifts – Between More ❯

and commercial off-the-shelf (COTS) systems used throughout our pharmaceutical operations. This role is essential to ensuring compliance with GAMP 5 guidelines and global regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11), while also supporting a company-wide risk stratification initiative for all GxP-relevant systems. As a CSV Specialist your … areas (e.g., manufacturing, quality control, clinical operations). Excellent written documentation, communication, business process analysis and stakeholder engagement skills. Why Join Us? Joining the Target Healthcare Group means being part of an inspired, enthusiastic team committed to our vision and values. We believe in cultivating a nurturing, dynamic workplace culture. Career Progression and professional development opportunities Flexible Shifts – Between More ❯

date knowledge with current and proposed pharmaceutical regulations. Essential Skills and experience: Experience working in QA/IT/IS on a pharmaceutical manufacturing site with working knowledge of 21 CFR Part 11, EudraLex volume 4 Annex 11 and Good automated manufacturing practice (GAMP). Very good communication skills and demonstratable experience of working as … part of cross functional teams. Experienced in working with cross functional teams to identify and implement changes and improvements within pharmaceutical manufacturing and warehousing environments. Must have excellent communication, influencing and troubleshooting skills. Ability to effectively contribute within a team environment and work on own initiative. Meticulous attention to detail. Excellent planning and organisational skills. Ability to work accurately 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 ❯

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 ❯

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 ❯

pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. … Familiarity with infrastructure considerations (networking, hosting, security, etc.) in enabling on-premise and cloud IT solutions. Knowledge of data integrity and compliance standards within a GxP-regulated environment (e.g., 21 CFR Part 11). Solution architecture certifications for Microsoft Azure or Google Cloud Platform. Experience working in a product operating model delivering architecture capability across product. 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 ❯

driving secure, scalable DevOps practices across the organization. This includes building and automating infrastructure, championing compliance-ready CI/CD pipelines, and aligning system architecture with regulatory requirements (HIPAA, 21 CFR Part 11, FDA SaMD guidelines). You will work cross-functionally with engineering, product, compliance, and leadership teams to deliver infrastructure that meets the highest More ❯