MSAT Powder Expert

Belgium, Verviers

MSAT Powder Expert is a Subject Matter Expert position. His expertise includes but is not limited to process validation, powder manufacturing technologies, manufacturing environment, powder analytical testing and product know-How. MSAT Powder expert leads powder process (re)validation, powder process changes, powder process critical & tehnical investigations, powder process recipe design:

  • Lead powder process (re)validation.
  • Ensure a proper communication between all concern departments. Supervise all validation activities with production team.
  •  Ensure validation documentation is clear, scientifically based and in compliance with European GMP, ISO13485 expectations, 21CFR820.This includes also when necessary execution of validation tasks.
  • Ensure powder process is maintained in a validate state of control
  • Lead technical investigations and support experiments for demonstration of potential root causes
  • Lead powder process change/improvement projects
  • Provide exhaustive planning and accurate budget evaluation for projects.
  • Provide support to other MSAT projects.
  • Keep up to date knowledge in manufacturing technologies and Science related to product

Skills:

  • Proven experience powder product manufacturing
  • Strong scientific knowledge in powder form chemicals and blended products
  • High level of autonomy
  • Strong analytical and problem solving skills with pragmatic approach. Proven ability to perform investigations and use root cause analysis tools
  • Strong organizational skill. Ability to build accurate project planning and budget.
  • Good understanding of cGMP and validation principles
  • Strong knowledge of Microsoft Office software’s (Excel, PowerPoint, Word)
  • Basic statistical knowledge is mandatory
  • Advanced statistical knowledge is an asset
  • Fluent: French and english
  • Master degree Sciences, biotechnology, Chemistry or Biology
Reference: R42414