Principal Statistician

Job Description

Duties and Responsibilities:

• 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).