What are the responsibilities and job description for the Sterility / Aseptic Engineer position at Fusion Life Sciences Technologies LLC?
Title: Sterilization Associate
Location: Warsaw, IN
Duration: 12 Months
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
· Reviews routine sterilization records and performs sterility release for sterile implants
· Assists in the review and classification of new and modified products
· Assists in the execution of validation and process improvement projects
· Executes special projects in the Environmental/Microbiology Services Laboratories
· Represents Sterilization Technology Department on cross function teams to address manufacturing issues, cleanroom issues, new product development, nonconforming product investigations, etc.
· Educates department personnel, manufacturing personnel, and development personnel on concepts in instrument reprocessing and industrial sterilization
· Assists with and/or prepares departmental documentation (Zimmer Work Instructions, test protocols, validation documents, technical reports, etc.) for review and approval
· Provides technical guidance to internal and external customers on issues pertaining to microbiology, clean room technology, instrument reprocessing, and industrial sterilization
· Represents Zimmer as an alternate on AAMI Standards Committees.
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.