16 of 16 21 CFR Part 11 Jobs in England

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 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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯