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Process Design Engineer

Catalent Pharma Solutions

Brussels, Belgium

Responsibilities

  • Design and implement the process to the detail for new products for both Packaging and Manufacturing activities;
  • Perform process design with focus on the product characteristics, equipment and facility characteristics, the operational efficiency and quality/risk approach;
  • Design, perform and evaluate accuracy studies on a scientific basis, e.g. pumps studies, kinetic studies, VI studies, etc.;
  • Be the process Expert for auto-injection devices;
  • Lead and participate in risk assessment exercises;
  • Build processes following Quality By Design: CQA, CPP, CIPC, etc.;
  • Support the PV steps;
  • Define URS for specific equipment part of the process.

Qualifications

  • Engineering degree;
  • At least 5 years’ experience in the pharma industry;
  • Fluency in English is mandatory;
  • QBD expertise and proven experience;
  • Demonstrated experience with auto-injector devices is a strong asset;
  • Both hands-on and customer oriented;
  • Presentation skills for both internal site/customer/forums/seminars;
  • Risk analysis focused;
  • Team player working in cross-functional teams.

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