Provides microbiology/sterility assurance support to the R&D Sterile Manufacturing facility for all product, people and material processes related to contamination control
Job Summary
Provides microbiology/sterility assurance support to the R&D Sterile Manufacturing facility for all product, people and material processes related to contamination control.
Oversee and develop improvements in training for sterility assurance of operators (aseptic practices, gowning, gloving).
Adopt and drive adoption by others of data and digital tools to drive continuous improvement and deliver simplified, efficient business processes.
Matching Summary
Provides microbiology/sterility assurance support to the R&D Sterile Manufacturing facility for all product, people and material processes related to contamination control.
Skills & Requirements
Must-have
Microbiological control of materials
Contamination control for sterile manufacturing
GMP requirements and corporate policies
Microbiological testing and validation
Environmental monitoring
Bioburden testing
Bacterial endotoxin testing
Nice-to-have
Quality systems development
Microbiology modernization initiatives
Digital data activities
Aseptic practices training
Partnership interfaces
Investigate aberrant results
New technology investigation
Key Requirements
BS (+5 years), MS (+3 years), PhD (+0 years) in Microbiology or related field
3+ years environmental monitoring experience
3+ years routine bioburden testing experience
3+ years bacterial endotoxin testing experience
3+ years pharmaceutical manufacturing experience
Experience working in aseptic environments
Experience training employees in Aseptic techniques