The posting
Position: Specialist - Plant Hygiene Department: Quality Reporting Structure: Director - Quality Reporting to this position: No direct reports POSITION PURPOSE: The purpose of this position is to identify, assess, mitigate, and maintain microbial risks within the facility at acceptable levels to ensure product safety, quality, and regulatory compliance. This role is responsible for overseeing microbial risk management across all areas of the plant, including risks originating from external sources such as suppliers, raw materials, and service providers. The position works proactively to reduce or eliminate factors that may introduce microbial hazards into manufacturing processes, thereby protecting operational integrity, product quality, consumer safety, and overall business performance. RESPONSIBILITIES:
Partner with Validation, Maintenance, Production, and Compounding teams to develop, validate, and continuously improve preventive maintenance, cleaning, and sanitization programs based on microbial risk assessments. Author, revise, and maintain cleaning and sanitization SOPs; train personnel on proper cleaning practices, aseptic techniques, and microbial contamination prevention. Support cleaning validation activities, including complete equipment tear-downs, inspections, sample collection, and investigations. Conduct routine audits of manufacturing areas, analyze findings, and implement corrective actions to mitigate microbial risks. Manage environmental monitoring programs, including sampling strategies, data trending, and establishment of alert and action limits. Lead microbial-related Out-of-Specification (OOS) investigations, perform root cause analyses, initiate non-conformances when necessary, and track corrective and preventive actions. Perform microbial risk assessments, research microorganism species, and provide technical expertise to support quality and compliance objectives. Collaborate with internal teams and customers to establish microbial specifications, testing methods, sampling plans, and cleaning requirements. Support regulatory and customer audits, annual product reviews, document reviews, and other quality system activities. Serve as a subject matter expert on microbial control and act as a liaison between Quality and operational departments to ensure compliance and minimize contamination risks. Assist with evaluating and recommending process improvements, equipment upgrades, and sanitization solutions to enhance microbial control. Perform other duties as assigned by the Director of Quality
Education & Experience
Bachelor's degree in Microbiology preferred; other life science disciplines may be considered based on relevant experience. Minimum of 5 years of experience in a manufacturing environment, preferably within the food, pharmaceutical, consumer products, or chemical industries. At least 2 years of experience in cleaning and sanitization of manufacturing equipment, with knowledge of hygienic equipment design and sanitation principles. Working knowledge of microbial control programs, environmental monitoring, root cause investigations, and contamination prevention practices. Experience with quality and regulatory standards, including ISO 9001, Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and USP requirements, is preferred. Lean Manufacturing and Six Sigma training, certification, or practical application experience preferred. Strong analytical, problem-solving, communication, and cross-functional collaboration skills, with the ability to train personnel and drive continuous improvement initiatives.
PHYSICAL DEMANDS:
Work is performed in both manufacturing and laboratory environments and may involve exposure to wet or humid conditions, moving mechanical equipment, airborne particles, and cleaning or sanitizing chemicals. Exposure to moderate noise levels is expected within manufacturing and processing areas. Occasional travel may be required to support audits, training, supplier assessments, or business needs. Required PPE includes safety glasses and other protective equipment as dictated by specific work areas, tasks, or company safety procedures. Laboratory activities may require the use of a lab coat, gloves, and other applicable protective equipment. Compliance with all company health, safety, hygiene, and PPE requirements is mandatory.
This position is classified as exempt. Competitive Benefits Package We offer a comprehensive and competitive benefits package designed to support the health, well-being, and financial security of our employees. Benefits include, but are not limited to:
Medical, Dental, and Vision Insurance 401(k) Retirement Plan Short-Term and Long-Term Disability Coverage Life Insurance Paid Vacation Time Paid Sick Leave Paid Holidays Performance-Based Annual Bonus
Eligibility and benefit offerings may vary based on employment status and company policy.
