Sterilization Manager
Abbott AG
Clonmel, ,Ireland
14d ago

JOB DESCRIPTION :

In Ireland, Abbott employs almost 3,000 people across 10 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third party manufacturing management operation in Sligo.

It has commercial, support operations and shared services in Dublin. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals.

Abbott has been operating in Ireland since 1946.

Abbott Ireland Vascular Division Clonmel

Abbott Vascular is one of the world's leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-

class pharmaceuticals, investing in research and development and advancing medicine through training and education.

Our broad line of vascular devices which includes vessel closure, endovascular and coronary technologies are used to treat vessel diseases of the heart, carotid arteries and peripheral blood vessels.

These vessel diseases can lead to heart attack, stroke, critical limb ischemia and other serious vascular conditions.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

1. Leads team that conduct sterilization qualification for new products and / or changes to existing products.

2. Leads team that performs sterilization validation for radiation sterilized products including dose setting and quarterly dose audits.

3. Leads team that performs sterilization validation for ethylene oxide sterilized products including new product qualification, annual revalidations, residual EO studies, and D-

value studies.

4. Leads team that provides product development and Operations teams sterilization Subject Matter Expert support

5. Leads team that assist in Supplier Quality audits of contract sterilization facilities and third party manufacturers.

6. Leads team that conducts dose audit failure investigations.

7. Leads team that conducts Ethylene Oxide Biological indicator sterility positive investigation.

Education

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.

Experience

Technical / Business Knowledge (Job Skills)) 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. Failure to adequately perform tasks can result in noncompliance with governmental regulations.

Cognitive Skills) 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.

JOB FAMILY : Medical & Scientific Affairs

DIVISION : AVD Vascular

LOCATION : Ireland >

ADDITIONAL LOCATIONS : United Kingdom >

WORK SHIFT : Ie - Coreflex (Ireland)

TRAVEL : Yes, 10 % of the Time

MEDICAL SURVEILLANCE : Not Applicable

SIGNIFICANT WORK ACTIVITIES : Not Applicable

Not Applicable

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