18000 Devonshire Street Sherwood Forest, CA 91325 US
- 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.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.