21 of 21 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 ❯

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 ❯

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 ❯

PoE, AV-over-IP, BICSI, ITIL, and network architecture. Experience working with project delivery models (e.g., EPCM, Design-Build, IPD). Knowledge of relevant regulatory and cybersecurity frameworks (e.g., 21 CFR Part 11, ISO/IEC 27001). Excellent stakeholder management, communication, and organizational skills. Fluent in English; additional languages (German, French, etc.) are an asset … on pharmaceutical campuses, labs, or manufacturing facilities. What We Offer: Competitive compensation and performance-based bonuses. Work with leading-edge technologies in a purpose-driven organisation. Opportunity to be part of global flagship facility projects. Strong focus on professional development, health & wellness, and diversity & inclusion. More ❯

PoE, AV-over-IP, BICSI, ITIL, and network architecture. Experience working with project delivery models (e.g., EPCM, Design-Build, IPD). Knowledge of relevant regulatory and cybersecurity frameworks (e.g., 21 CFR Part 11, ISO/IEC 27001). Excellent stakeholder management, communication, and organizational skills. Fluent in English; additional languages (German, French, etc.) are an asset … on pharmaceutical campuses, labs, or manufacturing facilities. What We Offer: Competitive compensation and performance-based bonuses. Work with leading-edge technologies in a purpose-driven organisation. Opportunity to be part of global flagship facility projects. Strong focus on professional development, health & wellness, and diversity & inclusion. 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 ❯

maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the … commissioning, and validation. Soft Skills: Strong leadership, communication, and technical writing skills. Comfortable working in cross-functional teams and adapting standard principles to complex challenges. Why Join Us? Be part of a pioneering R&D setup with direct influence on design and operations. Thrive in a dynamic, innovation-driven environment with clear opportunities for progression. Enjoy a competitive salary More ❯

maintain control systems using PLC, DCS, HMI, and SCADA technologies. Write and review key documentation (URS, SDS, IQ/OQ/PQ, SOPs) and ensure compliance with GAMP and 21 CFR Part 11. Support system lifecycle activities, including change control and system upgrades. Troubleshoot control systems and instrumentation, perform root cause analyses, and recommend improvements. Lead the … commissioning, and validation. Soft Skills: Strong leadership, communication, and technical writing skills. Comfortable working in cross-functional teams and adapting standard principles to complex challenges. Why Join Us? Be part of a pioneering R&D setup with direct influence on design and operations. Thrive in a dynamic, innovation-driven environment with clear opportunities for progression. Enjoy a competitive salary More ❯

a laboratory environment Demonstrated strong customer service skills Strong planning, organizational, negotiation and problem-solving skills. Excellent written, verbal, and strong interpersonal skills. Knowledge of regulatory compliance standards, i.e. 21 CFR part 11 Fluency in English, French is seen as an added value 10% travel Labcorp is proud to be an Equal Opportunity Employer: Labcorp strives More ❯

expertise in software development and project management. Proficiency in both Agile/SCRUM and Waterfall methodologies is essential, as well as comprehensive understanding of regulatory frameworks such as FDA 21 CFR Part 11. The ideal candidate will be a confident leader and team motivator, capable of combining strategic thinking with strong communication, interpersonal, and customer service skills. More ❯

expertise in software development and project management. Proficiency in both Agile/SCRUM and Waterfall methodologies is essential, as well as comprehensive understanding of regulatory frameworks such as FDA 21 CFR Part 11. The ideal candidate will be a confident leader and team motivator, capable of combining strategic thinking with strong communication, interpersonal, and customer service skills. 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 ❯

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 ❯

of solutions aligned with stakeholder expectations Serve as a key liaison between technical teams and business units Regulatory Compliance Lead technology compliance efforts aligned with international standards (e.g., FDA 21 CFR Part 11, GAMP 5, ICH GCP) Conduct internal audits and support external audits from regulatory authorities and partners Drive risk assessments and implement mitigation strategies More ❯

Rockwell Automation portfolio of products such as Studio5000 & FactoryTalk Software especially FT View SE, FT Batch). Knowledge of Batch Process Control, ISA-S88 standard programming. Knowledge of GAMP, 21 CFR Part 11, ASTM E2500, GMP, etc Knowledge of Virtualisation technology. What We Offer: Comprehensive mindfulness programs with a premium membership to Calm Volunteer Paid Time 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 ❯

correctly and align with the company EDMS whilst adhering to procedures for Document Control. Cross-check documents with pre-existing quality documents. Provide document drafting, review and approval as part of equipment and software purchase and implementation. With the help of management and quality teams link quality work instructions to pre-existing SOPs. Ensure smooth day-day administrative operations … in/with Regulatory and Validation teams and QA would be beneficial. Having drafted User Requirement Specification, Validation Plans and be aware of IQ/OQ/PQ and 21 CFR Part 11 would be advantageous. Strong IT skills and knowledge of Microsoft Office Suite, principally, Word. Excellent organisational and time-management skills. Excellent record keeping More ❯

controlled documents. Support the project team as they work towards execution and handover Requirements: 3+ years experience of life sciences experience Knowledge and illustrated experience of working with GAMP, 21 CFR Part11 etc. Excellent ability to work with others showcasing strong communication and organisational skills Prior experience of working in automation projects is preferred 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 ❯

Writing and reviewing technical documents (specifications, technical reports, risk assessments). Experience with additional PLC/HMI/SCADA manufacturers. Awareness of regulatory expectations around computerised systems (GAMP5, FDA 21 CFR11, EU ANNEX 11. Company: Our client is improving people's lives and health outcomes by focusing on areas of high unmet medical need. Location: This role is located More ❯