16 of 16 21 CFR Part 11 Jobs in the UK

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 ❯

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 ❯

consistency across regulatory processes. 10+ years of experience in software lifecycle management and validation, with emphasis on pharma or biotech compliance. Solid knowledge of EU regulatory frameworks (e.g., GxP, 21 CFR Part 11, Annex 11). Experience preparing for and navigating ISO, SOC, and other third-party compliance audits. Strong documentation, project management, and cross 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 ❯

communication networks, control panels, HMI, MES, SCADA, PLC and Historians. Broad and in-depth knowledge with practical experience of computer and application validation (preferably using GAMP methodology ), cGMPs , and 21 CFR Part 11 in an FDA regulated environment. Proven experience in lead ing and manag ing teams effectively, with a strong track record of fostering a More ❯

independently whilst establishing a high-trust environment with the client's counterparts. Main Job Tasks and Responsibilities: Implement software systems in conformance with regulatory requirements as they pertain to CFR 21 Part 11. Ensure compliance with corporate initiatives and company standards. Develop and maintain a comprehensive IT Quality Assurance Program in support of the company's pipeline. … applications. Assist to create test transactions and run tests to find errors and confirm programs meet specifications. Consult with suppliers to prototype, refine, test, and debug programs to attain CFR 21 Part 11 compliance/approval. Write and maintain documentation to describe program development, logic, coding, testing, changes, and corrections. Provide technical assistance by responding to … information is missing, convoluted, and/or unclear. Effective verbal and written communication skills. Ability to clearly document and report testing-effort results. Ability to work independently or as part of a team in the resolution of problems and completion. Knowledge of IT QA procedures and processes including acceptance testing procedures, defect tracking, benchmarking, process simplification and effectiveness improvement More ❯

feedback. Emit structured telemetry events to data pipelines for model retraining. Ensure WCAG 2.2 AA compliance, semantic HTML, keyboard navigation, and screen-reader support. Adhere to internal branding and 21 CFR Part 11 considerations in regulated contexts. Own GitHub workflows: branching strategy, GitHub Actions pipelines, automated testing, and artifact deployment. Containerize and deploy the SPA via 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 ❯

About the Role We're hiring a Pre-Sales Technical Consultantto join a dynamic, mission-driven team transforming the way clinical trials are run. As part of a fast-growing healthtech startup, you'll play a key role in supporting commercial growth by bridging the gap between client needs and product capability. You'll work closely with both the … SaaS, cloud, or digital health. Strong understanding of enterprise sales cycles and client engagement across regulated industries. Clinical trial tech knowledge and familiarity with sector-specific standards (e.g. GCP, 21 CFR Part 11, GDPR) is a major plus. Excellent communication skills with the ability to present technical topics to both technical and non-technical audiences. Comfortable More ❯

decision making in life sciences quality and compliance. The company's solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for We are looking for Salesforce Implementation … to become an integral part of our Professional Services team at Dot Compliance. At Dot Compliance, we strive to ensure customers' satisfaction and an effective onboarding process. As a Salesforce Implementation Specialist, you will work closely with the professional services global team to support technical activities during customer onboarding stage, develop custom solutions, tools and scripts to improve the … platform, allows life science customers to manage their quality and compliance Our ideal candidate should be passionate about learning new technologies, organizing information data, and keen on becoming a part of a growing and dynamic team. You will succeed in this role if you are a problem solver who likes to work with data and people to drive the 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 ❯

systems, HMI packages, building management systems, SCADA systems, and PC networking technology Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11 More ❯

and standards for all applicable markets, including but not limited to: Hazardous Chemicals: UK & EU REACH, RoHS, California Proposition 65, AB1200 Food Contact Materials: EU 10/2011, FDA 21 CFR 175-178 Electrical & Electronic Products: Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), Battery Directive (2006/66/EC 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 ❯