Manager, Microbiology

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Location:

Clearwater, FL.

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The Microbiology and Sterilization Manager is responsible for leading microbiology laboratory operations, environmental monitoring programs, and sterilization processes to ensure compliance with regulatory requirements, company quality standards, and industry best practices. This includes the development, manufacturing and release of medical device product.

• Lead and manage microbiology laboratory operations, ensuring compliance with cGMP, ISO 13485, and FDA regulations.
• Oversee microbiological testing programs, including bioburden, endotoxin, sterility, and microbial identification.
• Ensure laboratory equipment calibration, maintenance, validation and qualification are performed as required. Maintain inventory of reagents, media, and supplies.
• Supervise, train, mentor, hire and develop microbiology lab staff. Oversee laboratory personnel in the day‑to‑day laboratory functions and workload demands. Develop and maintain SOPs, work instructions, and training programs.
• Participate in laboratory OOS investigation to identify root cause, corrective action, and timely implementation of CAPA.
• Provide technical guidance to manufacturing during investigations, process/product changes, and new product development.

• Manage sterilization processes (e.g., steam, ethylene oxide, gamma, or other modalities) including validation, requalification, and routine monitoring.
• Develop and maintain sterilization validation protocols and reports in compliance with ISO 11135, ISO 11137, and related standards.
• Partner with manufacturing, engineering, and suppliers to ensure sterilization processes meet product and regulatory requirements.
• Oversee Sterilization Process including batch records review and validations (new validation or annual requalification).

• Oversee environmental monitoring programs, Water Monitoring System and site microbial contamination control program for clean rooms/ controlled environments.
• Lead investigations into environmental excursions and implement corrective and preventive actions (CAPA).
• Lead and participate on project teams that improve performance in Contamination Control/Operational Control Program driving manufacturing and laboratory excellence for the site.
• Lead and coordinate microbiological risk assessments for laboratory operations, ensuring alignment with corporate quality, safety, and regulatory requirements.
• Review trend analysis of EM, water testing, product testing and other test data as necessary.

• Oversee product release activities, ensuring all microbiological, sterility, and quality criteria are met prior to release product to distribution.
• Review and approve risk assessments related to new methods, equipment, or process changes before implementation.
• Collaborate with Quality and Regulatory Affairs to resolve any discrepancies or nonconformances before release.
• Support internal and external audits (FDA, ISO, Health Canada, EU Notified Bodies, etc.) including documentation support and CAPA responses.
• Maintain up‑to‑date knowledge of microbiology, sterilization science, and regulatory expectations.

• BS or MS degree in Science, Microbiology, Biology or related discipline.
• Strong knowledge of sterilization validation standards (ISO 11135, ISO 11137, ISO 17665) and microbiological testing per USP and ISO standards and working knowledge of microbial , USP sterility and bioburden test methods.
• Expertise in microbiological principles and applications related to microbial , validation and clean room technology. Trained in cGMP for laboratory operations and compliance to regulatory guidelines.
• Knowledge in Sterilization Process (Steam, Radiation and EO).
• Strong grasp of global quality and regulatory requirements including cGMP, ISO 13485, and 21 CFR Part 11 compliance.
• Ability to manage multiple projects and priorities in a fast‑paced environment.
• Strong leadership,…