Microbiologist

Position Title: Microbiologist

Position Purpose: The Microbiologist will conduct routine testing on finished products, raw materials, personnel, and environmental samples. They will apply microbiological expertise to the operation of the facility’s microbiological laboratory and support sanitary manufacturing. This role serves as a resource for environmental monitoring, investigation, method transfer/validation, and equipment validation.

Scope: The Microbiologist works as part of the mill Microbiological Laboratory team, applying technical expertise to routine testing, evaluating data, identifying trends, and ensuring compliance with applicable procedures and regulations. The role also supports continuous improvement efforts. The Microbiologist reports to the Quality Manager and Microbiology Lab Leader, and operates with limited direction for day-to-day tasks.

Customers:

• Manufacturing Operations
• Microbiology Team
• Quality Assurance
• Suppliers
• Purchasing
• BCC Staff and Global Quality Teams
• Planning
• Logistics/Distribution
• Research
• Engineering

Position-Specific Accountabilities:

• Microbiological Testing & Interpretation:
• Perform routine microbiological testing on finished products (e.g., baby wipes), production materials, environmental samples (air, surfaces, personnel testing, water), and specialized testing for troubleshooting or improvement projects.
• Ensure all testing and work complies with established Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Interpret results from microbiological tests, including Gram stain, Lanagram, Staph Latex, Catalase, etc., for timely product release.
• Conduct growth promotion tests as needed.
• Identify microbial species using VITEK technology.
• Regulatory Compliance & Auditing:
• Maintain compliance with GLP and GDP.
• Support facility regulatory audits by maintaining full compliance with procedures and resolving any gaps.
• Conduct routine audits of operating areas, sanitization procedures, and laboratory activities to ensure conformance to standards and verify training effectiveness.
• Data Management & Reporting:
• Track, trend, and communicate microbiological data promptly, highlighting issues that require action.
• Prepare and execute test method transfers, validations, and equipment qualifications.
• Record and communicate non-conformities as needed.
• Properly document all quality incidents and ensure they are reported and communicated.
• Review logbooks per GDP requirements and work to improve GDP compliance.
• Support Continuous Improvement:
• Participate in continuous improvement activities for established processes and support the development of new processes.
• Support troubleshooting and problem-solving related to microbiological investigations of non-conformities.
• Support cleaning and sanitization / Clean-In-Place validations.
• Collaboration & Training:
• Work closely with the Microbiology Team, Quality Assurance, and other departments to support quality control and product release.
• Provide technical expertise in microbiology to assist with investigations and audits.
• Conduct periodic training and development sessions as needed.
• General Responsibilities:
• Ensure the microbiological laboratory operates according to regulatory standards.
• Create, review, and update relevant documents and procedures.
• Identify quality issues and, if necessary, shut down operations to address them.
• Flexibility to support a 7-day operation as needed.

Required Qualifications / Education / Experience:

• Education: Bachelor's Degree in Biology, Microbiology, or a related scientific discipline.
• Experience: 5 years of microbiological lab experience in regulated product manufacturing (food, cosmetic, drug, medical device, pharmaceutical), with direct involvement in methods validation, lab equipment qualification, and test methods transfer.
• Skills:Understanding of GLP, environmental monitoring, and data trending.
• Proficiency with data analysis software (EtQ, SAP Batch Management, LIMS, Minitab, JMP).
• Strong Microsoft Office skills (Excel, Word, PowerPoint).
• Ability to influence others, with strong interpersonal skills and the ability to adjust communication to different audiences.
• Excellent problem-solving skills for root cause analysis.
• Ability to work independently and manage time effectively.
• Additional Requirements:Availability to work five days per week, including Fridays, Saturdays, Sundays, Mondays, and Tuesdays. Flexibility to support a 7-day operation.
• Minimum age of 18 years.
• Legal right to work in the United States.