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