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Microbiologist Job


Medtronic


US  -  Memphis, Tennessee 
Job Code - 69647
Position - Full Time - Regular
Job First Active on: Monday, November 02, 2009

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JOB DESCRIPTION: Microbiologist

Works on assignments that are complex in nature where judgment and initiative are required in resolving problems and making recommendations. Provides input to Principal Microbiologist regarding sterilization, testing and technical issues. Works with the contract sterilizers to maintain sterilization cycles using either Gamma Sterilization or Ethylene Oxide Sterilization in accordance with all industry, Federal and international guidance documents/regulations. Interacts with the Regulatory, Quality, Packaging and R&D Engineering in Memphis to maintain the microbiological specifications and test plans necessary to ensure compliance with the overall Quality Requirements. Assists with microbiological and sterilization issues affecting manufacturing. Serves as consultant for laboratory on technical issues. Develops procedures for laboratory testing. Minimal supervision.

REQUIREMENTS - QUALIFICATIONS: Microbiologist

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned:

Interact with Purchasing and Contract Sterilization/Test Facilities to ensure the Sterilization requirements and product testing procedures are clear, complete and understood.

Work with internal personnel, as well as the Contract Sterilization and Test facilities to establish specifications and coordinate the new product sterilization validations as well as the quarterly validations.

Coordinate yearly and quarterly product re-verifications (Irradiation & Ethylene Oxide).

Coordinate lethality testing for EtO product, or process qualifications.

Conduct Product Release (EO & Gamma).

Develop and coordinate steam sterilization studies.

Develops and Coordinates Reusable Device Validation (Cleaning Studies).

Develop and coordinate profiling protocols.

Develop equipment validations (steam, dry heat, incubators).

Document all test procedures and validations.

Provide guidance to other non-exempt personnel within and outside the department.

Act as technical advisor for customers and projects regarding sterilization, contamination control, GLP, process qualification, and test documentation.

Review and revise manufacturing related documents, protocols and procedures ensuring manufacturing needs are met.

Review laboratory protocols for accuracy, consistency, and compliance with applicable standards.

Develop procedures for process/product development testing and test methods that meet industry standards and Medtronic QA and Corporate Compliance requirements. Use experience and technical expertise to assist department.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and EXPERIENCE REQUIREMENTS:

Bachelor’s Degree in Microbiology or related field from an accredited college or university and a minimum of two (2) years experience in a medical device, pharmaceutical or cosmetic field
Minimum of one (1) year experience in Sterilization Validation Processes

Medtronics


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