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Automation Engineer

Central London   •  Negotiable  •  Permanent, Full time

Our client is a clinical-stage gene therapy biotech company focused on developing potentially curative treatments for patients living with serious diseases. They are currently recruiting for an Automation Engineer to work at their manufacturing facility who can quickly build up their internal expertise in their current Operational Technology systems, to improve system robustness and reduce our dependency on specialist suppliers.

Major Activities:

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.

Preparation of and input into equipment and System URS, Design Qualifications, Data Integrity assessments to ensure that Equipment and Systems meet user and Qualification requirements.

Review vendor equipment and system Functional Design Specifications (FDS), Hardware Design Specifications (HDS) and Software Design Specifications (SDS) as required.

Provide technical oversight of Vendor FAT, SAT, IQ, OQ testing, to ensure that the systems meet Meira Standards

Responsible for automation and engineering support on Vendor Packaged Equipment, Building Management Systems, and Environmental Monitoring System, including monitoring, maintaining, trouble shooting and investigating control system hardware, wiring, and instrumentation, including out of hours support for manufacturing activities.

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.

Raise and complete Quality Events, change controls, CAPAs, and Deviations for automated GMP systems and equipment into the site QMS system.

Proactively search for and implement innovative solutions to improve system performance, reliability, and compliance.

Support training efforts for new equipment installations

Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures

Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken

Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state

Job Background

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.

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

Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.

Proven programming and maintenance experience with DCS, PLCs and Software applications, ideally across a number of industrial platforms

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

Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus

Works and communicates well in a multi-discipline team structure

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

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

  • Agency: Cpl Life Sciences
  • Reference: JO-2205-491722
  • Posted: 4th May 2022
  • Expires: 1st June 2022

Cpl Life Sciences

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