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Prin Microbiologist-Steriliz

Sherwood Forest, CA 91325

Posted: 03/20/2023 Employment Type: Contract Job Category: Scientific Job Number: 546687 Is job remote?: No Country: United States

Job Description

Must Have
  • Cleanrooms
  • Cleanroom validation
  • Environmental Monitoring

Nice To Have
  • CEA Environmental Monitoring, CEA Environmental Validation, EO Sterilization Process Validation.
  • Radiation sterilization

Top Skills needed:
  • We will be combining our site procedures with enterprise procedures, performing gap assessments and implementing changes.  Once this is complete, we will move into potential cost savings implementation by reducing sample sizes/frequencies with justification from applicable standards, historical performance and risk assessment.
    • Strong understanding of Environmental monitoring and related standards for cleanrooms used to manufacture terminally sterilized products
    • Understanding of microbiological methods and related standards– product bioburden testing and bacterial endotoxin testing (also known as LAL)
  • CAPA and Nonconformance experience is desired. They will not own any however will support functional workload in this area.
  • Knowledge of e-beam radiation sterilization a plus. 

Responsibilities may include the following and other duties may be assigned.

This position may specifically support:
-Qualifications and on-going support to controlled envrionments/cleanrooms.
-Assessment/Implementation of microbiological methods and risk-based sampling plans supporting sterility assurance including environmental monitoring, product bioburden, and bacterial endotoxin testing
-Evaluations of supplier changes impact to sterility assurance of on-market products
-Improvements to site environmental and sterility assurance procedures/practices including remediation.
-Other related duties as assigned.
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