IR
Principal Sterilization
Integrated Resources, Inc
🇺🇸 United States
Remote
Staff / Principal
3 months ago
- Agile
3 months ago
Not enough detail in this posting to match
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)
Principal Sterilization · Integrated Resources, Inc