Senior Microbiologist – Sterile Manufacturing

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.