Senior Microbiology Technician GMP Environmental Monitoring

Kincell Bio, LLC; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Kincell Bio is seeking a highly motivated QC Microbiology Technician III to join the Quality Control team in Durham, NC. This role focuses on environmental monitoring of cleanrooms, microbial testing of materials, and coordination with outside labs to ensure GMP compliance.

The ideal candidate will have a microbio degree (or equivalent experience), strong aseptic technique, and experience with environmental monitoring, bioburden, endotoxin and sterility testing in regulated settings.

Qualifications

• Bachelor's degree in microbiology or related field with 2+ years lab experience, or 5+ years in lieu of degree.
• Experience performing environmental monitoring in cleanrooms or controlled environments.
• Experience in GMP-regulated pharmaceutical/biotech environments.
• Proficiency with microbiological methods including environmental monitoring, bioburden, endotoxin, microbial enumeration, growth promotion, Gram staining, subculture, identification, and sterility testing.

Responsibilities

• Perform routine environmental monitoring of classified cleanrooms and laboratory areas.
• Coordinate environmental testing with external contract labs and review final reports.
• Perform microbiological QC testing of raw materials and in-process materials.
• Perform sterility testing and method verification per approved procedures.
• Review data, trend microbiological results, and contribute to technical reports.
• Assist with investigations and investigations into atypical results or excursions.
• Assist with qualification/validation of microbiology equipment, processes, facilities, and analytical methods.

Skills

Environmental monitoring

Cleanroom gowning

Data analysis & trending

Technical report writing

Independent work

Problem solving

Education

Bachelor's degree in Microbiology

Tools

LIMS

BacT/ALERT 3D System

Microsoft Office

Job description

Kincell Bio is seeking a highly motivated QC Microbiology Technician III to join the Quality Control team in Durham, NC. This role focuses on environmental monitoring of cleanrooms, microbial testing of materials, and coordination with outside labs to ensure GMP compliance.

The ideal candidate will have a microbio degree (or equivalent experience), strong aseptic technique, and experience with environmental monitoring, bioburden, endotoxin and sterility testing in regulated settings.