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Automation SME

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  1. CAPEX Projects
22-11-2023
32446
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Automation SME - Life sciences - 24-Month Contract+ 

Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for an Automation SME to help support operations at their Maryland facility.

With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide – and this is your opportunity to be involved!


Key Accountabilities:
  • URS’s GEP and GMP Automation part only
  • System upgrade requirements – GEP and GMP Automation part only
  • Agreed recipe handling functionality
  • Voice Data and communications documentation IFD (process)
  • Control System Architecture and User Requirements IFD
  • System Architecture drawing
  • Process Automation System Architecture IFD
  • Setting and agreeing the Automation Design Philosophy, in alignment with the Automation and IT strategies, technical standards and guidelines and local realties and expectations.
  • Setting and agreeing the automation parts of the project deliverable list, including the Automation and IT RACI.
  • Providing technical guidance to C&Q, and CSV throughout the project.
  • Lead the Automation User Requirements in alignment with relevant standards and guidelines.
  • Champion the timely engagement, review and approval of URSs with Customer team.
  • Supporting the Project Manager, Technical Project Manager, Work Package Owners, other SME’s with interpretation of the agreed Automation Design Philosophy and User Requirements.

Beneficial skills and experience:
  • Bachelor’s Degree in Engineering Field
  • 7 years’ experience in Pharmaceutical, Biologics or similar heavily regulated manufacturing operation
  • Knowledge of GMP equipment and utility automation design, operation and maintenance.
  • Large scale GMP Facility or equipment design through to operational handover experience

If this role is of interest to you, please apply now! 

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

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

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