4 of 4 21 CFR Part 11 Jobs in Buckinghamshire

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 ❯

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 ❯

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 ❯