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Sterilization Microbiologist

Classified As seen in RIjobs.com
Sterilization Microbiologist

Requisition ID 31880

Full/Part Time x

Location

Coventry

RI

Description

Sterilization Microbiologist

Purpose/Role Statement

Execute sterilization process validation activities within BSC sterilization facilities. Provide oversight of assigned Sterilization Department objectives and related technical support of Corporate Sterilization objectives.

Position Summary

This position is responsible to manage the execution of sterilization process validation and development/test runs with little direction and need for oversight of time management. The Sterilization Microbiologist 2 (Coventry Validation Coordinator Emphasis) must ensure that validation and development runs are staged and processed in a timely manner according to provided protocols and local procedures.

Major Responsibilities

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Execute Ethylene Oxide sterilization process validation and test/development runs in BSC Coventry.

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Interface with sterilization operations group at BSC Coventry and Corporate Sterilization Services to schedule sterilization validation and development runs.

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Collect and configure data from sterilization process validation and development runs and assemble data packet for submission to Quality Assurance.

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Consult on sterilization issues, support problem solving and resolution, and provide counsel to customers for related sterilization needs.

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Schedule, stage, and execute sterilization process validation and development/test runs at BSCCoventry.

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Work with sterilization operations at BSC sterilization facilities to schedule sterilization process validation runs.

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Stage process validation loads, as directed by Corporate Sterilization Services sterilization process validation protocols.

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Collect, configure, and assemble data generated as a part of the process validation runs and submit to QA for review.

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Communicate regularly with Corporate Sterilization Services regarding process validation status, priorities of process validation activities, and any failures encountered.

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Improve and manage validation systems and assure quality and compliance related information and data is accurate, reliable, and supports business objectives

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Develop, implement and maintain documentation systems, procedures and document

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formats to support process validation programs. Assure compliance with applicable

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standards, guidelines, corporate policies and regulatory requirements.

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Conduct or assist with sterilization process qualifications, data analysis, and report generation as required, assuring compliance with applicable standards, guidelines, policies and regulations.

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Assist with the generation of regulatory documentation and review of process submissions.

Education and Training

Requires a BS in Microbiology or related field; or demonstrates evidence of an acquired solid background of technical knowledge and experience in sterilization validations. Should have a minimum of 2 years of functional work experience in a medical device or regulated industry. It is a benefit to have sterilization operations or validation experience.
Boston Scientific 
Document ID: A4032-0S7B  
Ad Number: bostonscientific-31880
Job Type:  Regular

Job Schedule: Full-time


Published in:  RIjobs.com
Published on: 01/19/2010

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