Sr Microbiologist

MAIN PURPOSE OF ROLE

This position is for the microbiologist that consistently applies microbiological concepts to the manufacturing process
of a medical device and understands and develops process monitoring/metrics to maintain microbiological quality of
the final device.
**MAIN RESPONSIBILITIES**:
Provides Facility Microbiological Support
Record review of routine microbiological test results
Routine release of manufactured product
Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods.
Handles routine out of specification test results, or more complex out of specification issues.
Data analysis of sterilization processes.
Participate in audits of sterilization, test lab, and biological product vendors.
Documentation
Ensures correct documentation linkage flow for microbiologically related documents.
Writes new or updates current microbiologically related documents.
Maintains understanding of applicable standards and applies them to qualifications and test methods.
Writes protocols and reports for qualifications for sterilization and microbiological test methods.
Writes appropriate validation protocols; performs or oversees validations for new technologies, equipment, and/or test methods; creates documentation for implementation.
Develops sterilization cycles and laboratory test methods.
Works with technicians in conducting these qualifications.
Technical Training
Provides training to laboratory technicians on new equipment or new test procedures.
Provides training in the areas of sterilization validation and sterilization processes.
Authority to sign off Qualifications, DDAs, NCMRs, COs, FMEAs, PDP forms.
QUALIFICATIONS
- Bachelor's Degree or Master's Degree Microbiology or related science.
Microbiology, Science, Administration or related field
- 3 - 5 years in a medical device/pharmaceutical, or related industry in microbiology and/or sterilization roles.
- Experience in Environmental monitoring, Process and product monitoring in a Medical devices or pharmaceutical industry.
- Experience in Sterilization validation for Ethylene Oxide, Steam or Chemical sterilization processes.
- Fully Bilingual (English and Spanish)