- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Assist in development and review of User Requirements Specifications (URS).
- Suggest design modifications to address risks and design in quality and safety.
- Organizes, analyses and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
- Perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.
- Recommend, evaluate, and manage performance of contract resources
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
- Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
- Ensure safety during commissioning, validation, maintenance and manufacturing activities
- Support Manufacturing and QA with Performance Qualification (PQ) activities.
single use technologies, Inoculation, Bioreactors, Chromatography , Tangential Flow Filtration, validation processes, documentation, transfer technology