Senior Microbiologist - Aseptic EM & Sterile Manufacturing

IT Minds LLC; Camarillo (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

IT Minds LLC is seeking a Senior Microbiologist to support sterile biologics manufacturing with emphasis on Environmental Monitoring, bioburden, and endotoxin testing. The role requires hands-on lab work in Grade A aseptic environments and strict adherence to gowning protocols.

The candidate will collaborate with QC/QA, Manufacturing, and Validation teams to support production and product release activities, ensuring GMP compliance and proper documentation.

Qualifications

• Hands-on QC Microbiology in pharma/biotech/sterile manufacturing.

Responsibilities

• Perform routine microbiological testing for sterile biologics operations.
• Conduct Environmental Monitoring in classified cleanroom areas (Grade A/ISO 5).
• Perform bioburden and endotoxin testing on samples.
• Support viably monitoring including active air, surfaces, and personnel.
• Maintain equipment, media, reagents, and controlled documentation.
• Enter Grade A aseptic environments following gowning procedures.
• Review test results per GMP and Good Documentation Practices.
• Assist in investigations of excursions, contamination, and deviations.

Skills

QC Microbiology

Environmental Monitoring

Aseptic gowning

GMP knowledge

Investigations

Education

Bachelor's degree in Microbiology

Tools

Sterile manufacturing equipment

Job description

IT Minds LLC is seeking a Senior Microbiologist to support sterile biologics manufacturing with emphasis on Environmental Monitoring, bioburden, and endotoxin testing. The role requires hands-on lab work in Grade A aseptic environments and strict adherence to gowning protocols.

The candidate will collaborate with QC/QA, Manufacturing, and Validation teams to support production and product release activities, ensuring GMP compliance and proper documentation.