Principal Sterilization Process Specialist

4 days ago

Limerick, Limerick, Ireland beBeeSterilization Full time €50,000 - €60,000

Job Title: Principal Sterilization Process Specialist

About the Role:

We are seeking a highly skilled and experienced sterilization process specialist to join our team. As a principal sterilization process specialist, you will be responsible for developing and validating sterilization methods for medical devices.

You will work closely with cross-functional teams to establish acceptance criteria for sterilization and microbiology requirements of combination products. Additionally, you will conduct bioburden, BI, and BNF testing of medical devices.

Key Responsibilities:

  • Develop and validate sterilization methods for medical devices, including liquids, pre-filled syringes, polymers, and combination products.
  • Establish acceptance criteria for sterilization and microbiology requirements of combination products.
  • Conduct bioburden, BI, and BNF testing of medical devices.
  • Lead design reviews and recommend optimal sterilization procedures.
  • Ensure compliance with GMP practices and regulatory standards.
Required Skills and Qualifications:

To succeed in this role, you will need:

  • Experience in development, validation & commercialisation of various sterilization modalities such as Steam, EtO, Gamma, E-beam, and X-ray.
  • Strong communication skills and ability to collaborate with global vendors and cross-functional teams.
  • Experience supporting regulatory submissions for FDA and CE marking.

This is an excellent opportunity for individuals who are passionate about sterilization processes and want to contribute to the development of life-saving medical devices.

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