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FITS, LLC

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Principal Sterilization

PrincipalGeneralContractRemoteLeadTeam 51-200H1B No SponsorCompany SiteLinkedIn

Location

Puerto Rico

Posted

16 days ago

Salary

0

Seniority

Lead

Bachelor Degree3 yrs expSpanishEnglish

Job Description

Principal Sterilization

FITS, LLC

• 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

Job Requirements

  • 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

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

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