Principal Sterilization

Weil Group • Remote / Northridge CA / Puerto Rico, PR

2d • Remote

About The Position

We are seeking an innovative and strategic Principal Sterilization to lead our sterilization processes from development through commercialization. In this role, you will define global sterilization strategies, drive cutting-edge validation protocols, and ensure our life-saving medical devices meet the highest regulatory standards.

Requirements

• 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

Nice To Haves

• New Products knowledge
• Sterilization Qualifications Protocols Validation Documentation
• Fully Bilingual

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 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed