Principal Sterilization Specialist

Principal Sterilization Manager

Primary Talent Partners has a new contract opening for a Principal Sterilization Manager to join a global medical technology virtual. This is a 12-month contract with a potential for extension.

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.

Description

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.

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.

Qualifications

• 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)

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.