10 of 10 21 CFR Part 11 Jobs in the UK excluding London

integration experience with 3+ years hands-on SAP Integration Suite and S/4HANA integration patterns •? 5+ years life sciences industry experience with deep understanding of GxP regulations, FDA 21 CFR Part 11 compliance, and validation methodologies •? Design and develop complex integration flows connecting S/4HANA with LIMS, MES, QMS, and regulatory reporting systems using More ❯

Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence Ensure all processes adhere to industry standards, GxP regulations, FDA 21 CFR Part 11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Hands-on SAP functional More ❯

Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence: Ensure all processes adhere to industry standards, GxP regulations, FDA 21 CFR Part 11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Experience: At least 10+ More ❯

Partner to implement and troubleshoot end-to-end solutions, supporting a robust and scalable environment. Compliance and Regulatory Adherence Ensure all processes adhere to industry standards, GxP regulations, FDA 21 CFR Part 11, and internal governance frameworks. Monitor system performance and integration functionalities to support audit readiness and risk mitigation. Qualifications & Experience Hands-on SAP functional 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 ❯

systems like LIMS, SCADA/HMI, and PLC-integrated devices. Collaborate with infrastructure teams and vendors to resolve escalated issues. Ensure compliance with Computer System Validation (CSV), GxP, and 21 CFR Part 11 standards. Document support activities accurately using the IT helpdesk system. Deliver technical onboarding and system usage training to end users. Proactively recommend improvements More ❯

site. In this role, you will lead Computer Systems Validation across the site and support the execution of the Validation Master Plan. You will ensure compliance with regulatory requirements (21 CFR Parts 11, 211, 600, ISO 9001, ISO 13485) and provide guidance on validation issues. Your responsibilities will include participating in investigations for failures, managing CAPA, and More ❯

startup, and validation of process equipment and systems for capital projects of significant scope and complexity. Responsible for industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11, and GAMP. Development of detailed specification, engineering documents, SOP and operating standards. Ownership and administration of process control automation in a GMP regulated … and Personal Experience: B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering. Experience working with Emerson DeltaV DCS systems version 11 or above, Rockwell Automation Factory Talk & ControlLogix PLC Platform. Working knowledge of building automation systems, electronic batch records, PLC, OPC, Foundation Fieldbus, Profibus, and DeviceNet technologies, as well as More ❯

external vendors Support installation/configuration of validated and non-validated systems Assist in patching, updates, and system maintenance Ensure adherence to validation standards such as CSV, GxP, and 21 CFR Part 11 Maintain accurate support records via the helpdesk system Provide onboarding and training to end users Identify and propose improvements in IT services and 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 ❯