Microbiologist

Applied Medical•Rancho Santa Margarita, CA

About The Position

The Microbiologist supports microbiological testing and sterility assurance activities within Applied Medical's Biological Sciences Department. This role provides technical expertise in microbiological testing, validation, contamination control, and regulatory compliance for sterile medical devices while collaborating with Quality, Regulatory Affairs, R&D, and external testing laboratories.

Requirements

Bachelor's degree in Microbiology or related life science discipline (Microbiology preferred).
3-7 years of experience in microbiology testing laboratories supporting medical devices, pharmaceuticals, biologics, or contract testing services.
Hands-on experience with microbial identification, culture-based methods, gram staining, microbial characterization, and aseptic laboratory techniques.
Experience supporting microbiological testing and validation of sterile medical devices.
Experience performing and interpreting bioburden assessments, recovery studies, and contamination investigations.
Experience supporting FDA inspections and quality system audits.
Knowledge of sterility assurance principles and microbiological risk assessment.
Working knowledge of ISO/IEC 17025, FDA quality system requirements, and laboratory quality systems.
Working knowledge of microbiological standards applicable to sterile medical devices, including: ISO 11737-1 (Bioburden Determination), ISO 11737-2 (Sterility Testing), Applicable sterilization validation standards.
Familiarity with: USP <71> Sterility Tests, USP <85> Bacterial Endotoxins Test, USP <61> and <62> Microbiological Examination.
Experience with environmental monitoring, contamination control, and good laboratory practices.
Strong technical writing, analytical, troubleshooting, and communication skills.
Proficiency in Microsoft Office and electronic quality or laboratory management systems.

Nice To Haves

Master's degree in Microbiology or related scientific discipline.
Experience in the medical device industry and sterile product development.
Experience supporting FDA, ISO, Notified Body, and customer audits.
Experience executing microbiological validation protocols and authoring technical reports.
Experience with microbiological risk assessments, investigations, CAPA activities, and contamination control programs.
Experience managing external microbiology testing laboratories.
Experience with bioburden recovery method development, recovery efficiency studies, sterilization validation, and microbiological evaluations performed in accordance with ISO 11737 standards.
Knowledge of ethylene oxide, radiation, or other terminal sterilization processes.

Responsibilities

Oversee microbiological testing activities, including bioburden testing, microbial identification, environmental monitoring, sterility testing, endotoxin testing, and contamination control.
Troubleshoot testing workflows and recommend improvements that enhance efficiency, compliance, and data quality.
Ensure testing activities are conducted in accordance with laboratory procedures, FDA regulations, and applicable ISO and USP standards.
Guide and train Associate Microbiologists and Laboratory Technicians.
Support internal audits, supplier audits, and FDA inspections by providing microbiological expertise and technical support.
Participate in microbiological investigations, root cause analyses, contamination control initiatives, and CAPA activities.
Support microbiological evaluations associated with sterile medical device development, sterilization validation, packaging validation, and ongoing product monitoring.
Review microbiological test strategies, study results, and validation activities to ensure scientific rigor and regulatory compliance.
Serve as a subject matter expert on microbiological testing, sterility assurance, contamination control, and microbiological risk assessment.