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Process Automation SME

Process Automation SME

Quanta part of QCS StaffingBrussels
30+ dagen geleden
Functieomschrijving

Process Automation SME – Brussels – Life Sciences

We are looking for an experienced Process Automation SME for a fantastic 6 month contract based in Brussels.

Working with our client, a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease, you will lead all automation processes in scope for their new project.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities :

  • Lead the Automation topics in process scope
  • Understand and translate Automation functional specification to process SME to ensure URS&TRS requirements are fully answered.
  • Strong background within manufacturing M&B(Media and Buffer) or USP or DSP process equipment’s
  • Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required, as well as mass balances.
  • Strong knowledge of cGMP / GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
  • Perform Design review and Design Verification with the Engineering office and the CQV team
  • Lead and execute to the FAT / SAT of Equipment’s in the scope

Skills and experience :

  • Extensive experience working on large scale pharmaceutical projects
  • Strong Knowledge of PCS7 within Automation is essential
  • Strong knowledge of GxP requirements
  • Ability to manage key stakeholders (Engineering Office, User and Others)
  • Expertise in Automation for Biological processes especially media and Buffer prep
  • In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations
  • Expertise in single use systems within the pharmaceutical industry
  • Large experience in detailed design, equipment installation and commissioning

    • If this role is of interest, please apply now.

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