Senior Microbiologist

Stryker is hiring a Senior Microbiologist in Ventura, California to support TMJ Concepts! As a Senior Microbiologist, you will coordinate microbiological and/or chemical testing, sterilization validations, and the release of product and testing for validation protocols. You will perform organism identification and technical reviews of batch records to ensure the quality of aseptic processes. 

What you will be doing:

• 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).

What you need:

Required:

• 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.

Preferred:

• 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.

$76K - $118K salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.