Sterilization Subject Matter Expert

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
 

DESCRIPTION:

Job Title: Sterilization Subject Matter Expert

Under the direction of R&D, the sterility assurance specialist will be responsible for acting as a core team member in projects involving radiation (gamma and e-beam) and ethylene oxide sterilization of commercial laboratory consumables, including medical devices. The specialist will report to R&D, and support Manufacturing Operations and QA as needed. The specialist will work closely with sterilization suppliers, technicians, engineering, project managers, product managers, and packaging engineers to ensure that the product specific sterilization processes are properly validated and documented. The sterility assurance specialist will need to have effective time management and multi-tasking skills and have a team-player mindset.

Responsibilities:
• Assist local quality teams with the implementation of the sterilization program
• Generate sterility documentation such as protocols and reports
• Ensure that sterilization studies conform to the most current internationally recognized standards and applicable regulations
• Coordinate testing and maintain related documentation
• Work closely with contract sterilization providers for routine sterilization process development
• Review quarterly dose audits and annual re-validations

• Support customer, notified body, and regulatory audits as needed
• Assist with OOS (out of specification investigations) relating to bioburden, sterility, or environmental excursions on the manufacturing floor
• Provide regular project status updates to leadership team
• This position is site-based in Monterrey, Mexico

REQUIREMENTS:
• Science, Engineering, or technical degree (preferably Microbiology, Biochemistry, Biology, Chemistry, or related field)
• Fluent in English and Spanish
• Minimum of 2 years' experience in a role related to sterilization
• Experience in regulated environment (cGMPs, ISO 13485, ISO 9001, etc.)
• Familiarity with ISO, AAMI, ASTM standards relating to sterilization and related topics