Sterility Assurance Microbiologist Lead

Becton Dickinson NA; Sumter (SC); On-site; USD 65,000 - 90,000; Full time

Job summary

Becton, Dickinson and Company in Sumter, South Carolina is seeking a Sterility Assurance lead to ensure sterile product quality and compliance. The role involves supervising microbiology labs, overseeing environmental monitoring, and refining sterilization cycles.

The successful candidate will guide corrective actions, maintain equipment, and ensure adherence to GMP and FDA expectations in a cleanroom environment.

Qualifications

• BA/BS in Biology or Microbiology with 12 hours Microbiology coursework (or 5 years in microbiology lab).
• 2–3 years lab supervisory experience required.
• Sterility assurance experience preferred.

Responsibilities

• Analyzes data and submits reports based on the data.
• Performs environmental monitoring of air, water, surfaces for microbial load and particulates.
• Maintains sterility and validates steam sterilization cycles.
• Supervises lab personnel and coordinates projects within Sterility Assurance.
• Develops and revises microbiology test specifications and procedures.
• Interacts with regulatory bodies regarding sterility and microbiology requirements.

Skills

Leadership

Microbiology

Sterility assurance

Data analysis

GMP/QA understanding

Education

Bachelor's degree in Biology/Microbiology

Tools

Autoclaves

Laminar flow hoods

Sterilization equipment

Environmental monitoring equipment

Job description

Becton, Dickinson and Company in Sumter, South Carolina is seeking a Sterility Assurance lead to ensure sterile product quality and compliance. The role involves supervising microbiology labs, overseeing environmental monitoring, and refining sterilization cycles.

The successful candidate will guide corrective actions, maintain equipment, and ensure adherence to GMP and FDA expectations in a cleanroom environment.