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Sterilization Process Lead

2 weeks ago

Cluain Meala, County Tipperary, Ireland beBeeLeadership Full time €800,000 - €1,000,000

Job Title: Sterilization Process Lead

About the Role:

The Sterilization Process Lead plays a pivotal role in ensuring compliance with corporate and divisional policies and procedures. This position leads teams in the execution of sterilization validation/revalidation, new product qualification, troubleshooting sterilization issues, and provides product development and operations teams with sterilization subject matter expertise support.

Key Responsibilities:
  • Leads team that conducts sterilization qualification for new products and/or changes to existing products.
  • Leads team that performs sterilization validation for radiation sterilized products including dose setting and quarterly dose audits.
  • Leads team that performs sterilization validation for ethylene oxide sterilized products including new product qualification, annual revalidations, residual EO studies, and D-value studies.
  • Provides product development and operations teams with sterilization subject matter expertise support.
  • Assists in supplier quality audits of contract sterilization facilities and third-party manufacturers.
  • Conducts dose audit failure investigations.
  • Investigates ethylene oxide biological indicator sterility positive incidents.
Requirements:

Bachelor's degree plus 9+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.

This role requires excellent leadership skills, strong analytical and problem-solving abilities, and effective communication skills. The ideal candidate will have a strong understanding of sterilization principles and processes, as well as experience working with cross-functional teams.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a challenging and rewarding role, please submit your application.