Perform a variety of assays supporting validation efforts for the new facility. Including but not limited to endotoxin (gel clot and kinetic method), sub-visible particulate, and biological indicator testing (BI). Proper GMP documentation guidelines will be adhered to as well as standards and requirements. Strong communication skills and the ability to work cross functionally across engineering, manufacturing, and quality is required.
- Bachelors degree in Microbiology, Biology, or related life science field
- Minimum 2+ years of experience as a microbiologist in a pharmaceutical manufacturing setting
- Experience with one or more of the following QC tests: endotoxin, BI, sub-visible, bioburden, and sterility
- Understands GMP documentation
- Prior experience with technical writing of SOP's or reports is a plus