6 of 6 21 CFR Part 11 Jobs in the UK excluding London

about Convatec, please visit Change is everywhere at Convatec. It's transforming our business, and helping us improve millions of lives. And we're nowhere near finished. Across every part of our business, we're pushing for better. Join us on our journey to as a System Owner/Technical Lead LIMS, and you'll do the same. Position … efficient, and well-documented LIMS configurations and scripts, following best practices and compliance standards. Participate in system reviews and validation activities to ensure system quality, regulatory compliance (e.g., GxP , 21 CFR Part 11), and data integrity. Troubleshoot, debug, and upgrade existing LIMS systems to ensure optimal laboratory operations and minimal downtime. Contribute to the full system … systems. Proficient in system configuration, scripting, and integration with laboratory instruments and enterprise systems (e.g., ERP). Strong understanding of laboratory processes, data management, and regulatory requirements (e.g., GxP , 21 CFR Part 11). Experience with software development methodologies (e.g., Agile, Scrum) and system validation practices. Familiarity with database technologies (e.g., SQL) and web services (e.g. More ❯

PharmaSuite (Rockwell), Syncade-DeltaV MES (Emerson), Werum PAS-X, or similar is strongly preferred. Additional Preferences Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11). Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. Strong documentation skills and attention to detail … to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of … skills, and geographic location. The anticipated wage for this position is $63,750 - $180,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation 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 ❯

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 ❯

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 ❯

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 ❯