Job Description
Allow me to introduce you to Kutol Products Company, we are a thriving hand soap and hand sanitizer manufacturer operating out of our Silver LEED Certified facility in Sharonville, Ohio. We process and package both cosmetic and drug formulas that work with our proprietary dispensing systems across the country and beyond. We are currently seeking a Site Microbiologist to join us in our purpose of providing "Clean Hands for a Healthy World."
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.
Microbiological lab operations, lab standards and procedures
- Qualification of micro lab personnel in methods and procedures
- Compliance to required microbiological operating standards and procedures
- Microbiology Daily Management System
- Microbiological investigations
- Compliance with relevant GMPs and other regulations applicable to Kutol and its customers
The responsibilities of this position include:
Microbiology Daily Management System - 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.
Microbiological Control
- 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.
Sanitary Design
- 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.
Cleaning and Sanitization
- 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.
Contamination Response
- 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.
Requirements
Education and Experience - 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.
Knowledge, Skills and Ability
- 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.
Physical/Mental Requirements:
- Ability to walk plant floor, negotiate step ladders, and work in plant conditions in order to audit/observe operations.
- Combination sit 60% Stand/Walk 40% of the time
- Exposure to chemicals, fragrances, perfumes and maintenance products
- Hand-eye coordination and mental/visual stamina for sustained use of computers and data analysis
Benefits
As a company, we offer stability in a thriving industry and an environment that emphasizes our core values of respect, honesty and fairness. Standard hours are 8am - 5pm, but you'll have the freedom to craft your schedule to interface with our 3 shift operation. Salary for qualified candidates will be $90K annually. A review of your performance will be made after three months in the position, and performance and compensation reviewed on your one-year anniversary. Kutol's benefit package includes medical, dental, vision, 401K and more including profit-sharing when we succeed as a team.
Our TeamMates enjoy working at Kutol because of our shared-fate environment and stability as an established 100+ year old local company. Please note, we are a drug free & tobacco free workplace. Apply now and see why Kutol is a fantastic place to work.
Job Tags
Full time, Local area, Shift work,