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Senior Microbiologist
| Company | Stryker |
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| Location | Ventura, CA, USA |
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| Salary | $76000 – $118000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- B.S. in Microbiology, Biology, or related discipline.
- 2+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
Responsibilities
- Conduct microbiological testing (e.g., Bioburden, Microorganism Identification, Media Preparation, Growth Promotion, Endotoxin, Sterility Testing) using qualified laboratory equipment and procedures.
- Reviewing and approving microbiological testing data ensuring compliance to the applicable methods and regulatory standard requirements.
- Be the site lead for microbiology and sterilization (Ethylene oxide).
- Conduct environmental sampling to the manufacturing-controlled areas supporting the ECA (Environmental Controlled Area) Monitoring Program.
- Prepare reports related to microbiological analysis, ECA Monitoring Program, and monthly metrics.
- Review and approve data related to the microbiological testing ensuring compliance to requirements set forth in applicable standards and test methods.
- Train new and existing personnel on ECA controls, microbiology testing, and proper testing techniques, ensuring all applicable requirements are met.
- Assure the laboratory equipment is qualified, calibrated and within PM (Preventive Maintenance) program.
- Conduct analytical method qualifications, laboratory equipment validations, and support sterilization process validation.
- Provide support during audits (FDA, TUV or other related).
- Review and approve reports of Biological Indicators or sterility analysis (EtO).
- Coordinate and manage external laboratory testing according to procedures.
- Comply with Health and Occupational Safety politics (EHS).
Preferred Qualifications
- Knowledge of Ethylene Oxide (EO) Sterilization.
- Knowledge of Bioburden, Endotoxins, and Environmental Monitoring.
- Previous microbiology analyst experience with endotoxin and bioburden method validation experience; preferable in medical devices.
- Experience in mold identification is a plus along with biocompatibility data knowledge.
- Knowledge in identification of microorganisms.
- Knowledge in microbiology lab equipment installation, operational qualification validations, and microbiology and sterility testing.
