Principal Sterilization

FITS, LLC

Principal Sterilization role with a focus on EO sterilization processes for medical devices. Engage with contract sterilizers and ensure compliance with standards.

Posted 6/30/2026contractRemote • 🇵🇷 Puerto RicoLeadWebsite

About the role

Key responsibilities & impact

Develop, modify, qualify and implement Ethylene Oxide sterilization processes with contract sterilizers
Manage communications with contract sterilizers and laboratories for sterilization processes
Interpret and evaluate analyses against established specifications and recommend corrective action
Support assessment and implementation of environmental monitoring methods for cleanroom manufacturing

Requirements

What you’ll need

Bachelor’s Degree in Life Sciences or Engineering
Three (3) years of exposure in EO Sterilization activities within the Medical Devices Industry
Bilingual in Spanish and English
Ethylene Oxide Sterilization Process Validations per ISO 11135
Knowledge in supporting microbiological and chemical methods for EO sterilization
Knowledge of environmental monitoring requirements per ISO 14644 standards

Benefits

Comp & perks

Flexible, family-oriented work culture
Focus on well-being of resources and employees

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Ethylene Oxide Sterilization ProcessesProcess DevelopmentAnalytical EvaluationCorrective Action RecommendationCleanroom Manufacturing Support

Soft Skills

Communication Management