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Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This ground-breaking company is seeking an Automation Engineer to be accountable for designing, developing, implementing, and maintaining industrial computerized process control and process monitoring systems in a biopharmaceutical manufacturing cGMP environment.
- You will work closely with site and global stakeholders to define and deploy automation solutions including equipment, processes, and manufacturing execution systems.
- Translate business, technical, and regulatory requirements into systems-level solutions during development and deployment of automated processing technologies.
- Manage technical work streams with cross-functional stakeholders throughout entire project lifecycle, from concept to implementation.
- Lead and partake in evaluation of new technology and process automation for introduction into GMP manufacturing.
- Accountable for the site PLC-based Control System, Building Management Systems, and Environmental Monitoring System.
- Develop, review and/or approve Preventive Maintenance Plans, Standard Operating Procedures, IQ/OQs, commissioning protocols, user requirement specifications, acceptance test plans, Functional Specifications, Design Specifications, and drawings and diagrams.
- Work with site Quality and Computer System Validation personnel to ensure automation and control system GMP compliance.
- Implement and complete change controls, CAPAs, and Deviations for automated GMP systems and equipment.
- Proactively search for and implement innovative solutions to improve system performance, reliability, and compliance.
- Support training efforts for new equipment installations.
- Ability to work and communicate well in a multi-discipline team structure.
- You have a bachelor's degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with 5+ years' experience supporting or developing automated systems.
- Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
- Strong understanding of automation standards and architecture addressing batch process control, such as S88, and related automation systems, including process control systems, manufacturing execution systems, process data historians, and laboratory information management systems.
- Proven programming and maintenance experience with PLCs and Software applications, ideally across a number of industrial platforms.
- Knowledge of Building Management/Automation Systems.
- You are familiar with FDA GMPs and FDA regulations relating to biologic and drug products.
- You are familiar with FDA regulation 21 CFR Part 11 and/or EU Annex 11.
- Experience with supporting and maintaining automation and control system infrastructure, including PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, as well as proprietary equipment controllers and control systems.
- Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus.
- Demonstrates skills in requirements gathering, design, configuration, integration, and implementation of process control solutions for the manufacturing industry including batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, and PC networking technology.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.