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Automation Lead

  1. Amsterdam
Netherlands
  1. Permanent
Competitive Rates
  1. Life Sciences
22-10-2020
25282/AN

This vacancy has now expired

Automation Lead- London / Limerick - Permanent 

Brilliant Opportunity to support a rapidly growing Gene Therapy company with their transition into commercial manufacturing. The company will be looking for the individual to travel between their two projects in London and Limerick (Ireland).

The Automation Lead will be responsible for designing, developing, implementing, and maintaining industrial computerized process control and process monitoring systems (SCADA, PLC and HMIs) in a biopharmaceutical manufacturing cGMP environment in both London and Ireland.

Major Activities
  • Collaborate 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 participate in evaluation of new technology and process automation for introduction into GMP manufacturing
  • Responsible for the site PLC-based Control System, Building Management Systems, and Environmental Monitoring System, including monitoring, maintaining, trouble shooting and investigating control system hardware, wiring, and instrumentation.
  • 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.
  • Implement and complete change controls, CAPAs, and Deviations for automated GMP systems and equipment
Job Background
  • Bachelor's degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with 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, process data historians, and laboratory information management systems
  • Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
  • 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
If you believe this role matches your skills and experience please apply now!

The candidate must have the rights to work in the location stated in the job advert.

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