About this role
Role Overview
- Provide hands-on microbiology support for sterile operations, including aseptic processing, environmental monitoring, and gowning qualifications.
- Lead investigations of unexpected microbiological results and drive corrective actions with clear root cause and risk assessment.
- Perform and review routine microbiological testing: bioburden, sterility, endotoxin, microbial identifications, and water testing.
- Develop, revise, and approve microbiological methods, SOPs, and sampling plans that support product release and stability programs.
- Partner with manufacturing, quality, and development teams to define and implement contamination control and sterility assurance strategies.
- Support validation activities, method transfers, and evaluation of rapid microbiological technologies.
Requirements
- Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related scientific discipline.
- Minimum 3 years’ hands-on experience in a pharmaceutical, biotech, or sterile manufacturing microbiology laboratory.
- Experience with environmental monitoring, aseptic techniques, gowning, and contamination control.
- cGMP principles and experience working to regulatory quality standards.
- Experience performing bioburden, sterility, endotoxin testing, and microbial identifications.
Benefits
- Health insurance
- Professional development opportunities
- Collaborate with experienced colleagues across disciplines
- Inclusion and learning culture
- Shared purpose culture