Job Description

Microbiologist II

Orange County, CA

Summary

The Microbiologist II serves as a technical resource supporting environmental monitoring and microbiological quality programs within an aseptic manufacturing environment. This role provides subject matter expertise for microbiology testing activities associated with product manufacturing and facility operations. Success in this position requires strong collaboration across departments to maintain regulatory compliance, strengthen environmental control strategies, and drive continuous improvement. The Microbiologist II also leads and contributes to technical initiatives involving microbiological methods, testing systems, and quality processes.

Responsibilities

• Provide technical microbiology expertise in support of environmental monitoring and quality control programs within aseptic manufacturing operations.
• Lead or support projects related to microbiological testing processes, including method development, method transfer, and validation activities.
• Participate in qualification activities such as cleaning and sanitization studies and aseptic process simulations (media fills).
• Perform method validation and suitability assessments for microbiological testing, including sterility and bioburden methods.
• Review, analyze, and trend environmental, personnel, and utility monitoring data to support investigations, quality reviews, and continuous improvement initiatives.
• Investigate microbiological excursions, out-of-specification results, or adverse trends, including root cause analysis, risk assessment, and development of corrective and preventive actions (CAPA).
• Implement and monitor the effectiveness of corrective actions, procedure updates, and process improvements resulting from investigations or quality initiatives.
• Evaluate proposed process or procedural changes for potential impact on environmental monitoring and microbiology testing programs.
• Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, and Operations to support microbiological compliance and process improvements.
• Prepare and maintain technical documentation such as protocols, validation plans, deviation reports, and study summaries.
• Develop and present environmental monitoring trend reports for aseptic production areas.
• Provide technical input during cross-functional meetings and communicate findings and recommendations to leadership as needed.
• Support planning and execution of technical projects, continuous improvement initiatives, and process optimization efforts.
• Address complex technical issues using structured problem-solving and data analysis methods.

Laboratory Support Activities

• Maintain qualification in microbiological sampling techniques and laboratory test methods and perform testing activities as needed to support operational requirements.
• Train and mentor laboratory personnel on microbiology procedures, sampling techniques, and compliance expectations.
• Coordinate testing activities with external contract laboratories when additional capacity or specialized testing is required.
• Review laboratory and manufacturing documentation to ensure data accuracy, completeness, and regulatory compliance.
• Participate in vendor qualification and supplier audit activities as a microbiology subject matter expert when required.
• Support regulatory inspections, customer audits, and internal quality audits.
• Perform additional duties and special projects as assigned.

Qualifications

• Bachelor's degree in Biology, Microbiology, Biochemistry, or a related life sciences discipline.
• Approximately 3+ years of experience in a regulated biotechnology, pharmaceutical, or aseptic manufacturing environment.
• Strong technical knowledge of microbiology laboratory practices and contamination control principles.
• Hands-on experience with environmental monitoring programs and microbiological testing methods.
• Experience with method development, transfer, or validation activities is preferred.
• Strong analytical, troubleshooting, and problem-solving skills with attention to detail.

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