Senior Microbiologist
Senior Microbiologist
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Job Description
Stryker is hiring aSenior MicrobiologistinVentura 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 manufacturingcontrolled 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 pay is based on skills experience and other relevant factors.
Travel Percentage: 10Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race ethnicity color religion sex gender identity sexual orientation national origin disability or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.Required Experience:
Senior IC
Employment Type
Full-Time
