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Microbiologist - 58305489 - TV

Job Code: 58305489
Job Location: Minnetonka, MN
Category: Chemical Engineering
Last Updated: 08/16/2017
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Job Description:
We are looking for a Microbiologist that will facilitate day-to-day microbiology laboratory activities, including: scheduling and performance of routine environmental monitoring, water testing (bioburden and endotoxin), product testing (endotoxin), quarterly dose audit sample collection and submittal, data entry and maintenance of microbiology data, ordering of supplies and ensuring that the laboratory is adequately stocked, assist in the performance of investigations into environmental excursions, and general project support.
Responsibilities
• Make sure that production is in compliance with local and corporate policies (sampling plans, CEA behavior, etc.).
• Initiate Laboratory Investigations and Non-Conformance Reports, and perform investigations into Non-Conformances.
• The site Microbiologist will also consult with quality engineering and assist in limit excursion investigations.
• This position will consult and assist in making sure that new construction and remodeling are handled appropriately and that the correct amount of testing is being performed during and post construction.
• Trending of Site Environmental Monitoring data and periodic review/setting of Environmental Monitoring limits.
• Preparing for audits and presenting site Environmental Monitor data to auditors.
• Approval of sanitizers
• Support of sterilization validations for products
• Assessment of devices for biocompatibility per ISO 10993 standards
• Write and revise SOP's
• Develops and maintains product bio burden sampling plan, and ensures that products are validated for bio burden testing.
• Nonstandard tests and special projects such as equipment qualifications, trend charting, test development or test improvement will be assigned as needed.
• May train and/or provide work direction to technicians.
 
Requirements:
Quality Systems Duties and Responsibilities:
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Basic Qualifications
• BA/BS in Biology and 1+ years of experience.
• Previous experience in a medical device company.
 
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 58305489TV
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 

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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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