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FITS, LLC

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

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in Ethylene Oxide Sterilization Process Validations and environmental monitoring methods in cleanroom manufacturing, with strong communication skills for managing relationships with contract sterilizers and laboratories.

Highest-signal resume keywords
Ethylene Oxide Sterilization Process ValidationsISO 11135 ComplianceEnvironmental Monitoring RequirementsMicrobiological Methods KnowledgeBilingual in Spanish and English

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Ethylene Oxide Sterilization ProcessesProcess DevelopmentAnalytical EvaluationCorrective Action RecommendationCleanroom Manufacturing Support
Soft Skills
Communication Management
Industry Keywords
Medical Devices IndustryISO 14644 StandardsEnvironmental Monitoring Methods

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