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hims & hers · 6 days ago

Microbiology Manager

Gilbert, Arizona

Full-time

Onsite

Senior Level

5+ years exp

Hims & Hers is a leading health and wellness platform focused on redefining healthcare through personalized care. The Microbiology Manager will oversee the Environmental Monitoring Program and ensure compliance with relevant regulations while maintaining sterility assurance in the sterile pharmaceutical compounding facility.

Health CareLifestyleMen'sWellnessWomen's

Responsibilities

Develop, manage, and improve the facility’s Environmental Monitoring (EM) Program, including SOPs, design, and program validation

Provide microbiological input on facility cleaning and disinfection programs, including disinfectant efficacy verification

Define and maintain EM sampling plans (viable air, non-viable air, surface, and compounding personnel sampling in ISO Class 5, 7, and 8 areas)

Manage media qualification, incubation practices, and readings (interim and final)

Perform or oversee microbial detection, CFU enumeration, growth assessment, and collaborate with labs for species identification

Maintain a microbial flora library and investigate excursions with data trending, RCA, and CAPA implementation

Train and supervise personnel performing EM sampling; monitor aseptic technique compliance

Maintain accurate, compliant EM records and reports

Serve as SME and liaison with third-party labs; support audits and inspections

Stay up to date with regulations, best practices, and technologies in microbiological testing and EM

Qualification

MicrobiologyAseptic processingEnvironmental Monitoring (EM)CGMP complianceISO Class 5 cleanroomsMicrobial identificationContamination controlAnalytical skillsDocumentation skillsCross-functional teamwork