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Bausch + Lomb · 2 days ago

Manager, Microbiology

Clearwater, FL

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing sight for millions. The Microbiology and Sterilization Manager is responsible for leading microbiology laboratory operations and ensuring compliance with regulatory requirements and quality standards.

Health CareHealth DiagnosticsMedical

No H1B

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

Qualification

Microbiology laboratory managementSterilization validation standardsCGMP complianceMicrobial identificationEnvironmental monitoringLeadership skillsOperational excellenceProblem-solving skillsCommunication skills

Required

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 ID systems, USP sterility and bioburden test methods

Expertise in microbiological principles and applications related to microbial ID, 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, communication, and problem-solving skills

Ability to inspire, coach, and hold teams accountable

Commitment to driving operational excellence and innovation

10-15 years of microbiology experience in biopharmaceutical/medical device industry of which minimum of 5 years is in a lead or supervisory role

Company

Bausch + Lomb

Glassdoor3.6

We're a leading global eye health organization that is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life.

Founded in 1853

Rochester, New York, USA

10001+ employees