Sterilization Subject Matter Expert

PPD (Thermo Fisher)

Monterrey, Mexico
Radiation sterilization (gamma/e-beam)
Ethylene oxide sterilization expertise
Iso and aami standards familiarity
This role supports the global mission to make the world healthier by ensuring safe sterilization processes for medical devices

Job Summary

  • This role supports the global mission to make the world healthier by ensuring safe sterilization processes for medical devices.
  • The specialist will validate and document radiation and ethylene oxide sterilization methods in collaboration with suppliers and engineering teams.
  • Candidates must ensure all studies conform to current international standards while supporting regulatory audits and out-of-specification investigations.

Matching Summary

This role supports the global mission to make the world healthier by ensuring safe sterilization processes for medical devices.

Skills & Requirements

Must-have

  • Radiation sterilization (gamma/e-beam)
  • Ethylene oxide sterilization expertise
  • ISO and AAMI standards familiarity
  • cGMP and ISO 13485 regulated environment
  • Sterility documentation generation

Nice-to-have

  • Effective time management skills
  • Strong team-player mindset
  • Multi-tasking capabilities
  • Project status reporting experience

Key Requirements

  • Science or Engineering degree preferred
  • Minimum 2 years sterilization experience
  • Fluent in English and Spanish
  • Experience with cGMPs and ISO standards

Work Rights

Not specified

Tailored Resume

Cover Letter