What are the responsibilities and job description for the Senior Microbiologist Sterile Manufacturing position at IT Minds LLC?
Senior Microbiologist Sterile Manufacturing
Background
Our pharmaceutical client is seeking an experienced Senior Microbiologist to support microbiology and environmental monitoring activities within a sterile biologics manufacturing facility. This individual will provide hands-on laboratory and cleanroom support, with a strong focus on Environmental Monitoring (EM), bioburden, and endotoxin testing. The ideal candidate will have direct experience working in Grade A aseptic environments and be fully qualified in sterile gowning practices.
Key Responsibilities
- Perform routine microbiological testing in support of sterile biologics manufacturing operations.
- Conduct Environmental Monitoring (EM) within classified cleanroom areas, including Grade A environments.
- Perform bioburden and bacterial endotoxin (BET) testing on product, process, and/or utility samples.
- Perform viable environmental monitoring including active air, surface, and personnel monitoring.
- Support microbiological testing of water, raw materials, in-process samples, and finished products as required.
- Enter and work within Grade A aseptic environments while following established gowning and contamination control procedures.
- Review and document microbiological test results in accordance with GMP and Good Documentation Practices.
- Support investigations related to environmental excursions, microbial contamination, OOS/OOT results, and other microbiology-related deviations.
- Maintain microbiology laboratory equipment, media, reagents, and controlled documentation.
- Collaborate with QC, QA, Manufacturing, and Validation teams to support production and product release activities.
Qualifications
- Strong hands-on QC Microbiology experience within pharmaceutical, biotechnology, or sterile manufacturing.
- Experience performing Environmental Monitoring (EM), bioburden, and endotoxin testing.
- Direct experience working within Grade A / ISO 5 aseptic environments.
- Gowning certified/qualified with experience performing aseptic gowning and cleanroom activities.
- Knowledge of GMP microbiology practices, contamination control, and aseptic processing requirements.
- Experience supporting microbiological investigations and environmental excursions preferred.
- Biologics, mRNA, sterile injectable, or other aseptic manufacturing experience strongly preferred.