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Sr. Microbiologist

Sr. Microbiologist

The Denzel Group, an award-winning search firm, has been chosen to work with an industry leader in Baltimore on their quest for a talented Sr. Microbiologist. In this technical position you will drive continuous improvement, ensuring an effective Environmental Monitoring sampling/testing program supporting aseptic operations relating to gowning requirements, personnel/material flow, and cleaning/sanitization.

Responsibilities

  • Development of innovative microbiology ideas and strategies, as well as standards for monitoring and controlling manufacturing processes.
  • Lead microbiology analyst training.
  • Troubleshoot (OOS) test results, as well as investigation and support of CAPAs.
  • Troubleshoot microbially nonconforming manufacturing processes.
  • Interface with internal regulatory compliance and external Regulatory Authorities during on-site inspections.

Requirements

  • Relevant BS degree.
  • 10+ years’ relevant experience, such as lab testing, executing lab studies, developing and validating test methods to support Microbiological Quality / Sterility Assurance.
  • Experience in aseptic operations including Environmental Monitoring.
  • Experience in designing and/or sustaining control strategies intended to prevent microbiological contamination in manufacturing areas.
  • Experience leading projects and initiatives within budget.
  • Experience leading the troubleshooting process non-conformances, OOS test results, and failure investigations, and CAPAs.
  • Experience conducting audits of in-house Microbiology Labs, contract/external labs, manufacturing processes, and critical utilities (i.e. water systems, compressed gases, controlled environments).

To apply please email your application to mschroeder@thedenzelgroup.com

microbiology, microbiologist, test, environmental monitoring, aseptic, GMP, OOS, deviation, investigation, CAPA, lead.

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