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.
- 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.
- 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 email@example.com
microbiology, microbiologist, test, environmental monitoring, aseptic, GMP, OOS, deviation, investigation, CAPA, lead.