- Reference: CJ46303
- Job Type: Permanent
- Location: Munster, Tipperary
- Category: Science, Pharmaceutical & Food
Exciting oppotunitiy to join a leading Multinational Medical Device company in the Munster area. With 3 direct reports, this role will lead a technical team in the execution of sterilization validation/revalidation, new product qualification, troubleshooting sterilization issues.
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Leads team that conduct 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.
- Leads team that provides product development and Operations teams sterilization Subject Matter Expert support
- Leads team that assist in Supplier Quality audits of contract sterilization facilities and third party manufacturers.
- Leads team that conducts dose audit failure investigations.
- Leads team that conducts Ethylene Oxide Biological indicator sterility positive investigation.
- Bachelor’s degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience.
- Substantial knowledge of a Radiation and or Ethylene Oxide or other sterilization modality.
- Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships.
- Is recognized as an SME in work group and across functions.
- Ability to lead a technical team in the execution of sterilization validation/revalidation, new product qualification, troubleshooting sterilization issue.
- Will lead team performing this job in a quality system environment.
- Works on problems where analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Has broad knowledge of various technical alternatives and their potential impact on the business.
- 10% Travel involved
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email email@example.com
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