INACTIVE
Full-Time
Manager – Microbiology
Posted on 11/15/2025
Bausch Lomb
No salary listed
No H1B Sponsorship
Clearwater, FL, USA
In Person
Category
 Biology & Biotech (2) |
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Required Skills
Microbiology
Requirements
- BS or MS degree in Science, Microbiology, Biology or related discipline.
Responsibilities
- 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 cleanrooms/ 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.
INACTIVE