Site Microbiologist

Kutol Products Company • Sharonville, OH

93d • $90,000 - $90,000

About The Position

At Kutol, the Site Microbiologist is responsible for developing and implementing microbiological testing programs, assessments, and awareness initiatives to ensure site-wide compliance and contamination control. This role manages microbiological lab operations, personnel qualification, and adherence to GMPs and regulatory standards. The Site Microbiologist will report to the Director of Quality.

Requirements

• Bachelor’s degree in Microbiology or Engineering with microbiological specialization (e.g., Biotechnology, Food/Dairy Engineering).
• Strong technical understanding of microbiology in industrial processes, standards, and product testing.
• Strong investigative and documentation skills.
• Proficiency in microbiological testing methods (e.g., USP <60>, <61>, <62>, Gram stain, MALDI-TOF, 16S sequencing).
• Knowledge of lab safety standards and microbiological controls.
• Understanding of statistical sampling for data tracking and trending.
• Authority to halt production when contamination risks are identified.
• Effective leadership and change management capabilities.
• Familiarity with regulatory requirements (e.g., CFR 210/211 for OTC drugs).
• Strong communication and collaboration skills to coach and influence site leadership.

Responsibilities

• Conduct regular microbiological assessments across manufacturing processes, environments, raw material handling, water systems, and hygiene practices.
• Ensure all samples are tested per approved methods with full traceability.
• Establish and manage the site’s microbiological testing laboratory in compliance with validated methods and procedures.
• Hire, supervise and evaluate Micro Lab Technicians.
• Collaborate with the Plant Hygienist to develop and maintain a Micro Daily Management System, including test types, frequency, data trending, and action/alert levels.
• Review microbiological data with Operations and recommend corrective actions.
• Prepare and present monthly reports to QA and site leadership.
• Implement and enforce lab controls, standards, and procedures.
• Ensure only approved methods are used for testing incoming materials.
• Conduct method suitability/validation for new products or materials before production.
• Train and qualify lab technicians in all required methods and document training records.
• Promote microbiological risk awareness across the site.
• Integrate microbiological training into the site’s overall training plan.
• Partner with the Plant Hygienist to implement sanitary practices in manufacturing.
• Ensure personnel are trained in aseptic sampling techniques.
• Evaluate proposed changes to products, processes, or maintenance to preserve microbial integrity.
• Participate in change control processes and update the Micro Daily Management System accordingly.
• Train Maintenance, Engineering, and other teams on microbiological principles.
• Identify and recommend improvements to equipment design to reduce contamination risks.
• Support development of robust sanitization procedures for microbiologically susceptible systems.
• Establish sanitizer usage strategies, including rotation protocols.
• Define microbiological limits and test methods for cleaning and sanitization validation.
• Review sanitization logs regularly for procedural compliance.
• Lead and document all microbiological contamination and out-of-specification investigations.
• Define sampling plans to assess contamination scope.
• Advise leadership on severity and response strategies for microbial incidents.
• Ensure timely identification of contaminant organisms using appropriate methods.
• Prepare risk assessments and recommend remedial actions.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401K
• Profit-sharing when we succeed as a team

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 101-250 employees