Automation Engineer

Automation Engineer

Location: London

Our client is a gene therapy company that works with gene therapy discovery, development and GMP manufacturing. They have headquarters in London and the USA and have recently redesigned exciting new labs with cutting edge technology and the ability to work to a higher standard and increase their capacity of production.

They are currently seeking an ambitious engineer who can build up internal expertise and improve the systems throughout their teams.

Key Responsibilities:

1. Translate technical, and regulatory requirements into systems-level solutions.
2. Manage technical work streams with stakeholders throughout the entire project lifecycle.
3. Preparation and input into equipment and System URS, Design Qualifications, Data Integrity assessments to ensure that they meet requirements.
4. Review vendor equipment and system Functional Design Specifications (FDS), Hardware Design Specifications (HDS) and Software Design Specifications (SDS) as required.
5. Provide technical oversight of Vendor FAT, SAT, IQ, OQ testing, to ensure that the systems meet Standards.
6. Responsible for automation and engineering support on Vendor Packaged Equipment, Building Management Systems, and Environmental Monitoring System.
7. Develop, review and approve Preventive Maintenance Plans, Standard Operating Procedures, IQ/OQs, commissioning protocols, user requirement specifications, acceptance test plans, Functional Specifications.
8. Design Specifications, and drawings and diagrams.
9. Work with site Quality and CSV personnel to ensure automation and control system GMP compliance.
10. Raise and complete Quality Events, change controls, CAPAs, and Deviations for automated GMP systems and equipment into the site QMS system.
11. Support training efforts for new equipment installations.
12. Responsible for ensuring that own work complies with GMP, Data Integrity and GDP and is undertaken in accordance with applicable procedures.

Skills Required:

1. Bachelor's degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with minimum 5 years' experience, supporting or developing automated systems.
2. 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 and process data historians.
3. Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
4. Proven programming and maintenance experience with DCS, PLCs and Software applications, ideally across a number of industrial platforms.
5. Experience with supporting and maintaining automation and control system infrastructure, including DCS, PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, as well as proprietary equipment controllers and control systems.
6. Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus.
7. 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.
8. Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products.
9. Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11.