Microbiologist

Essential Functions

• Analyzes and interprets data and submits reports based on the data.
• Conducts and analyses environmental monitoring of air, water, manufacturing surfaces and components for Microbial load and particulate levels.
• Actively identifies out-of-specification conditions and participates in identification of appropriate corrective actions to maintain minimum sterilization cycles and product quality.
• Ensures accurate performance of media preparation to insure sterility, accurate pH, and growth support and validated steam sterilization cycles.
• Assists in the development and revising of microbiology test specifications and procedures.
• Operation and maintenance of all laboratory equipment, including annual service and calibrations.
• Performs tasks using aseptic technique. Performs tasks in a Clean Room environment.
• Performs general microbiological procedures such as plating, staining, streaking / subculturing, and identification of isolates.
• Performs analysis of raw materials, components, finished products, and plant water for unacceptable microbial contaminates.
• Performs, calculates and records results of pre-sterile microbial load studies, sub dose audits/ minimal dosage studies, bacteriostatic/fungistatic analysis, sterility tests, pyrogenicity test (LAL), and additional tests conducted in the Microbiology Laboratory.
• Prepares and issues reports relevant to data acquisitions and participates in special projects as determined by Manager of Sterilization Assurance. Supervises laboratory procedures, analyzes and interprets data and submits reports based on the data. Has direct supervision of all laboratory personnel.
• Coordinates and outlines projects for laboratory personnel and evaluates their assigned task.
• Actively seeks corrective action to areas of high contamination critical to maintaining minimum sterilization cycles and product surface quality.
• Ensures proper performance of media preparation to ensure sterility, proper pH, and growth support to include m aintenance of stock cultures and validated steam sterilization cycles.
• Assists in the development of sterilization cycles for new or modified products.
• Reports status of laboratory testing on a periodic basis.
• Performs, assists, or directs routine laboratory procedures relative to sterility assurance, such as media preparation, product bacteriostatic tests, product contamination levels, classification of contaminants, development of procedures for new products and training of laboratory personnel on compliance with good laboratory procedures.
• Analyses environmental monitoring data and provides guidance to production supervisors on environmental improvements.
• Supervises the certification of laboratory staff on various test procedures.
• Assembles part or all technical data and materials cost packages for justification of new capital equipment.
• Maintains microbiological monitoring and cycle development programs for all types of sterilization processes (steam, ethylene oxide, Cobalt-60 irradiation) that aligns with procedures set forth by Global Sterility Assurance. Develops and implements corrective action programs for deviations to microbiological specifications.
• Approves and monitors procedures which have impact on product cleanliness (viable and non-viable).
• Review laboratory, and sterilization records for final release of product.
• Develops protocols and specifications for laboratory testing of medical devices to be sterilized and released.
• Prepares sterilization protocols and specifications for new or modified medical devices.
• Approves validation protocols and reports for new or modified processes where microbiological control is of
• significance.
• Ensures the delivery of sterile, non-toxic, non-pyrogenic products to market without biological quality defects.
• Interacts with FDA Inspectors, ISO Auditors, and Notified Body Reviewers regarding sterility assurance and microbiological requirements of the Quality Systems Regulations.
• Assists in the development and review of plant cleaning procedures. Works closely with facilities and manufacturing supervision on selection and proper use for cleaning agents.
• Conducts experimental projects and prepares laboratory cost estimates as required.
• Recommends actions for the control or eradication of unusual or high levels of contaminants.
• Maintains all laminar flow equipment, cleanrooms, incubators, autoclaves, and support equipment to ensure efficient and accurate laboratory testing.
• Prepares and maintains departmental budget and capital budget requests and reforecasts as appropriate.
• Responsible for the integrity, maintenance, and replacement of test instrumentation.

Additional Requirements

• Provides leadership, direction, and supervision for non-exempt associates, including writing performance reviews
• Performs other duties as assigned by Supervisor and required to support the needs of the business.

Minimum Requirements

• BA or BS Degree in Biology, Microbiology, or a Science subject area with a minimum of 12 hours of Microbiology coursework (will accept 5 years' experience in a microbiology lab in lieu of coursework) required
• 2- 3 years lab supervisory experience required
• Sterility assurance experience preferred

Work Environment

• BD is a smoke-free campus. Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas. We appreciate your cooperation in adhering to this policy
• False eyelashes, press-on fingernails, and Jewelry is not allowed on the production floor including dermals. Any associate wearing dermals will be required to cover them while working on the production floor.
• Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.