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Becton Dickinson

Global medical devices, lab equipment supplier

Microbiologist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSumter, SC, USANo salary listed

About the Job

Requirements

  • A BA or BS degree in Biology, Microbiology, or a science subject area with at least 12 hours of Microbiology coursework is required; five years of microbiology laboratory experience may substitute for the coursework.
  • Two to three years of laboratory supervisory experience is required.

Responsibilities

  • Analyze and interpret data and submit reports based on the data.
  • Conduct and analyze environmental monitoring of air, water, manufacturing surfaces, and components for microbial load and particulate levels.
  • Identify out-of-specification conditions and participate in identifying corrective actions to maintain minimum sterilization cycles and product quality.
  • Ensure accurate media preparation for sterility, pH, and growth support, and ensure validated steam sterilization cycles.
  • Assist in developing and revising microbiology test specifications and procedures.
  • Operate and maintain laboratory equipment, including annual servicing and calibrations.
  • Perform tasks using aseptic technique in a cleanroom environment.
  • Perform microbiological procedures including plating, staining, streaking, subculturing, and isolate identification.
  • Analyze raw materials, components, finished products, and plant water for unacceptable microbial contaminants.
  • Perform, calculate, and record pre-sterile microbial load studies, sub-dose audits and minimal dosage studies, bacteriostatic/fungistatic analyses, sterility tests, pyrogenicity tests (LAL), and other microbiology laboratory tests.
  • Prepare and issue reports relevant to data acquisition and participate in special projects determined by the Sterilization Assurance Manager.
  • Supervise laboratory procedures, analyze and interpret data, submit reports, and directly supervise laboratory personnel.
  • Coordinate and outline projects for laboratory personnel and evaluate their assigned tasks.
  • Seek corrective action for high-contamination areas that could affect minimum sterilization cycles and product surface quality.
  • Maintain stock cultures and ensure media preparation and validated steam sterilization cycles are performed properly.
  • Assist in developing sterilization cycles for new or modified products.
  • Report laboratory testing status periodically.
  • Perform, assist with, or direct routine sterility assurance laboratory procedures, including media preparation, product bacteriostatic tests, product contamination-level testing, contaminant classification, procedure development for new products, and training laboratory personnel on good laboratory procedures.
  • Analyze environmental monitoring data and guide production supervisors on environmental improvements.
  • Supervise certification of laboratory staff on various test procedures.
  • Assemble technical data and materials cost packages to justify new capital equipment.
  • Maintain microbiological monitoring and cycle-development programs for steam, ethylene oxide, and Cobalt-60 irradiation sterilization processes in alignment with Global Sterility Assurance procedures.
  • Develop and implement corrective action programs for deviations from microbiological specifications.
  • Approve and monitor procedures that affect viable and non-viable product cleanliness.
  • Review laboratory and sterilization records for final product release.
  • Develop protocols and specifications for laboratory testing of medical devices to be sterilized and released.
  • Prepare sterilization protocols and specifications for new or modified medical devices.
  • Approve validation protocols and reports for new or modified processes involving microbiological control.
  • Ensure delivery of sterile, non-toxic, non-pyrogenic products without biological quality defects.
  • Interact with FDA inspectors, ISO auditors, and notified body reviewers regarding sterility assurance and microbiological requirements of quality systems regulations.
  • Assist in developing and reviewing plant cleaning procedures and work with facilities and manufacturing supervision to select and properly use cleaning agents.
  • Conduct experimental projects and prepare laboratory cost estimates as required.
  • Recommend actions to control or eradicate unusual or high contaminant levels.
  • Maintain laminar flow equipment, cleanrooms, incubators, autoclaves, and support equipment for efficient and accurate laboratory testing.
  • Prepare and maintain departmental and capital budget requests and reforecasts.
  • Maintain the integrity, maintenance, and replacement of test instrumentation.
  • Provide leadership, direction, and supervision for non-exempt associates, including writing performance reviews.
  • Perform other duties assigned by the supervisor to support business needs.

Desired Qualifications

  • Sterility assurance experience is preferred.

About the Company

Becton Dickinson

Global medical devices, lab equipment supplier

BD (Becton, Dickinson and Company) is a global medical technology company that designs, manufactures, and sells medical devices, laboratory equipment, and related services for hospitals, labs, clinicians, and biopharma partners. It operates in four segments: Medical Essentials (medication delivery and specimen management devices), Connected Care (medication management and advanced patient monitoring systems), BioPharma Systems (drug delivery systems for pharmaceutical partners), and Interventional (surgical, endovascular, urological, and critical care products). In addition to devices, BD offers connected software, analytics, clinical education, customer portals, and service programs to support its products. The company’s goal is to help healthcare providers improve patient outcomes by enabling safer and more efficient delivery of care through integrated devices, data, and services across the health ecosystem.

Company size
10,001+
Company stage
IPO
Headquarters
Franklin Lakes, NJ
Founded
1961

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