Title: Principal Sterilization
Location: 100% Remote (Northridge CA)
Duration: 12 Months+ Possible Extension
Job Description:
Responsible for developing/modifying, qualifying and implementing Ethylene Oxide sterilization processes with contract sterilizers in accordance with ISO 11135 and applicable international standards.
Managing communications with contract sterilizers and/or laboratories in support of qualification of sterilization processes and associated microbiological/chemical methods (i.e. ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7)
Interprets and evaluates the analyses aProductst established specifications and recommends and implements corrective action where necessary.
Support assessment and/or implementation of environmental monitoring methods for cleanroom manufacturing of a terminally sterilized device in accordance with ISO 14644 series standards, EN 17141 and applicable standards.
May also be involved in establishing requirements for the transfer of methodology from R&D.
Required Skills:
Demonstrated Experience in Ethylene Oxide Sterilization Process Validations per ISO 11135 Knowledge in supporting microbiological and chemical methods to support EO sterilization per applicable standards: ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7
Knowledge of environmental monitoring requirements for manufacturing of a terminally sterilized device per ISO 14644 series standards, EN 17141.
Technical Skills:
Microsoft Office, Agile (preferred)
Numbers & Facts
Location
Remote, CA (Remote)
Skills
Agile Programming Methodologiesunmatched
American National Standards Institute (ANSI)unmatched
Analysis Skillsunmatched
Association for the Advancement of Medical Instrumentation (AAMI)unmatched
Cleanroomunmatched
Communication Skillsunmatched
Contract Managementunmatched
Contract Processingunmatched
Corrective Actionunmatched
Environmental Monitoringunmatched
Ethyleneunmatched
ISO (International Organization for Standardization)unmatched
Laboratoryunmatched
Manufacturing Methodsunmatched
Manufacturing Requirementsunmatched
Microbiologyunmatched
Microsoft Officeunmatched
Research & Development (R&D)unmatched
Sterilizationunmatched
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