Principal Sterilization Specialist

We are looking for a Principal Sterilization Specialist to join our team and provide sterilization and sterility assurance expertise to support Diabetes contract manufacturing operations, company product initiatives, and qualification of new sterilization partners., * 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 against 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.

Do you have experience in Quality standards in production?, Do you have a Bachelor's degree?, * Minimum of a completed Bachelor's degree, ideally in life sciences.

• 8+ years of 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
• Microsoft Office
• Agile (preferred)

4.54.5 out of 5 stars Remote $113 - $133 an hour - Contract, Pay: $113.00 - $133.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.