Sterilization Associate

Sterilization Associate

1 year Contract

Warsaw, IN

Duties

This position is responsible for performing a sterility assurance function with its primary purpose to develop, validate and monitor product sterilization processes in accordance with industry standards. This is accomplished through a wide variety of duties which support new product development, manufacturing operations, implant/instrument sterilization, and special projects in the Environmental/Microbiology Services Laboratories.

Principal Duties and Responsibilities %

• 15% - Reviews routine sterilization records and performs sterility release for sterile implants
• 15% - Assists in the review and classification of new and modified products
• 15% - Assists in the execution of validation and process improvement projects
• 15% - Executes special projects in the Environmental/Microbiology Services Laboratories
• 15% - Represents Sterilization Technology Department on cross function teams to address manufacturing issues, cleanroom issues, new product development, nonconforming product investigations, etc.
• 10% - Educates department personnel, manufacturing personnel, and development personnel on concepts in instrument reprocessing and industrial sterilization
• 5% - Assists with and/or prepares departmental documentation (Client Work Instructions, test protocols, validation documents, technical reports, etc.) for review and approval
• 5% - Provides technical guidance to internal and external customers on issues pertaining to microbiology, clean room technology, instrument reprocessing, and industrial sterilization
• 5% - Represents Client as an alternate on AAMI Standards Committees.
• 100% - Total Percent (not to exceed 100%)

*Individual percents should be greater than or equal to 5%.

Skills

This position is responsible for performing a sterility assurance function with its primary purpose to develop, validate and monitor product sterilization processes in accordance with industry standards. This is accomplished through a wide variety of duties which support new product development, manufacturing operations, implant/instrument sterilization, and special projects in the Environmental/Microbiology Services Laboratories.

Principal Duties and Responsibilities %

• 15% - Reviews routine sterilization records and performs sterility release for sterile implants
• 15% - Assists in the review and classification of new and modified products
• 15% - Assists in the execution of validation and process improvement projects
• 15% - Executes special projects in the Environmental/Microbiology Services Laboratories
• 15% - Represents Sterilization Technology Department on cross function teams to address manufacturing issues, cleanroom issues, new product development, nonconforming product investigations, etc.
• 10% - Educates department personnel, manufacturing personnel, and development personnel on concepts in instrument reprocessing and industrial sterilization
• 5% - Assists with and/or prepares departmental documentation (Client Work Instructions, test protocols, validation documents, technical reports, etc.) for review and approval
• 5% - Provides technical guidance to internal and external customers on issues pertaining to microbiology, clean room technology, instrument reprocessing, and industrial sterilization
• 5% - Represents Client as an alternate on AAMI Standards Committees.
• 100% - Total Percent (not to exceed 100%)

*Individual percents should be greater than or equal to 5%.

Education

• B.S. in Microbiology, Biology, Medical Technology, Engineering or other related field
• 0-3 years of relevant industry experience
• Other combinations of education and experience may be considered.