Senior Microbiologist

Title: Sr Microbiologist Location: CAPosition OverviewOur pharmaceutical client is seeking an experienced Senior Microbiologist to support microbiology and environmental monitoring activities within a sterile biologics manufacturing facility. This role will provide hands-on laboratory and cleanroom support, with a primary focus on Environmental Monitoring (EM), bioburden, and bacterial endotoxin (BET) testing. The ideal candidate will have direct experience working in Grade A/ISO 5 aseptic environments and be fully qualified in sterile gowning practices.Key ResponsibilitiesPerform routine microbiological testing in support of sterile biologics manufacturing operations.Conduct Environmental Monitoring (EM) in classified cleanroom areas, including Grade A/ISO 5 environments.Perform bioburden and bacterial endotoxin (BET) testing on product, process, utility, and other applicable samples.Execute viable environmental monitoring activities, including active air, surface, and personnel monitoring.Perform microbiological testing of water, raw materials, in-process materials, and finished products as required.Work directly within Grade A aseptic environments while adhering to established gowning, aseptic technique, and contamination control procedures.Accurately document and review microbiological test results in accordance with GMP and Good Documentation Practices (GDP).Support investigations involving environmental monitoring excursions, microbial contamination, OOS/OOT results, and microbiology-related deviations.Maintain microbiology laboratory equipment, culture media, reagents, supplies, and controlled documentation.Collaborate closely with QC, QA, Manufacturing, and Validation teams to support manufacturing operations and product release activities.Required QualificationsStrong hands-on QC Microbiology experience within a pharmaceutical, biotechnology, or sterile manufacturing environment.Proven experience with Environmental Monitoring, bioburden, and endotoxin testing.Direct experience working in Grade A/ISO 5 aseptic environments.Current or prior qualification in sterile gowning and aseptic cleanroom practices.Solid knowledge of GMP microbiology, contamination control, aseptic processing, and cleanroom practices.Experience supporting microbiological investigations, environmental excursions, deviations, and OOS/OOT events is preferred.Experience in biologics, mRNA, sterile injectable, or other aseptic manufacturing environments is highly desirable.