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Process Automation SME

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Life Sciences
36235
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Process Automation SME - Brussels, Belgium - 23 Months Contract

We are looking for an experienced Process Automation SME for a fantastic 23 months contract based in Brussels, Belgium.

You will be working with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

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:
  • Understand and translate Automation functional specification to process SME to ensure requirements are fully answered.
  • Strong background within manufacturing M&B(Media and Buffer) or USP or DSP process equipment
  • Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required.
  • Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
  • Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is required.
  • Ensure technical requirements are met within automation design provided by suppliers.
  • Include all technical requests in the URS for the commissioning and qualification.
  • Ensure for its Packages that deliverables will be provided timely and aligned with project planning with the right expected quality and according to the allocated budget.
  • Report the progress for its Packages.
  • Be accountable for its Packages and in strong collaboration with Automation Integrator company.
  • Align design expectations with the other project disciplines: Process, QA Q/V, Utilities, E&I, etc.
  • Anticipate, manage and report risks from Detail Design till validation batches.
  • Perform Design review and Design Verification with the Engineering office and the CQV team
  • Lead and Participate to the FAT/SAT of Equipment in the scope
  • Support the qualification phases after commissioning (ASTM2500)
  • Organise quality checks on field before each technical milestone activity.
  • Ensure a good communication with other Specialists linked to its activity (Battery limits)
  • Maintain his knowledge accuracy based on new technology. Keep up-to-date.
Requirements:
  • Extensive experience in in the pharmaceutical industry projects.
  • Masters Degree in Engineering/Automation
  • Expertise in Automation for Biological processes
  • In-depth technical experience in a regulated environment with knowledge of biologicals, pharmaceutical and engineering operations
  • Expertise in DCS system and preferably PCS7 (with Batch)
  • Large experience in detailed design, equipment installation and commissioning
  • Supporting qualification and validation activities
  • Good understanding of EHS (Environment, Health and Safety) and Quality aspects

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

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