Sterilisation Manager

Abbott Laboratories; Clonmel; On-site; EUR 70,000 - 90,000; Full time

Job summary

Abbott Laboratories is seeking a Sterilisation Manager for its Clonmel site. This role involves leading sterilization qualification processes, overseeing validation for various sterilization methods, and providing expertise to product development teams. The ideal candidate will have a Bachelor's degree and over 9 years of experience in a regulated environment, demonstrating strong leadership and analytical skills.

Qualifications

• Bachelor's degree plus 9+ years of relevant experience.
• Extensive knowledge of sterilization modalities like Radiation and Ethylene Oxide.
• Proven ability to lead a technical team in sterilization validation.

Responsibilities

• Lead the team conducting sterilization qualification for new and existing products.
• Oversee sterilization validation processes for radiation sterilized products.
• Manage sterilization validation for ethylene oxide sterilized products.

Skills

Analytical skills

Problem-solving

Leadership

Education

Bachelor's degree

Advanced degree preferred

Job description

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 colleagues, we serve people in more than 160 countries.

Abbott in Ireland

Operating since 1946, Abbott in Ireland serves the Irish market with a diverse range of healthcare products, including diagnostics, diabetes care, medical devices, and nutritional products. We employ about 6,000 people across ten sites in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford, and Sligo.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X, and YouTube.

Abbott Ireland Vascular Division – Clonmel

Abbott Vascular is a leading vascular care business focused on advancing vascular disease treatment and improving patient care through innovative medical devices, pharmaceuticals, research, development, training, and education.

Our vascular devices, including vessel closure, endovascular, and coronary technologies, are used to treat vessel diseases of the heart, carotid arteries, and peripheral blood vessels, which can lead to heart attack, stroke, and other serious conditions.

Purpose Statement:

The Sterilisation Manager is responsible for ensuring compliance with all applicable corporate and divisional policies and procedures.

Key Responsibilities:

1. Lead the team conducting sterilization qualification for new and existing products.
2. Oversee sterilization validation processes for radiation sterilized products, including dose setting and quarterly audits.
3. Manage sterilization validation for ethylene oxide sterilized products, including new product qualification, revalidations, residual EO studies, and D-value studies.
4. Provide sterilization SME support to product development and operations teams.
5. Assist in supplier quality audits of contract sterilization facilities and third-party manufacturers.
6. Lead investigations into dose audit failures.
7. Conduct investigations of Ethylene Oxide Biological indicator sterility positives.

Education

Bachelor's degree plus 9+ years of relevant experience or an equivalent combination; advanced degree preferred.

Experience

• Extensive knowledge of sterilization modalities such as Radiation and Ethylene Oxide.
• Recognized SME within the work group and across functions.
• Proven ability to lead a technical team in sterilization validation, troubleshooting, and product qualification in a regulated environment.
• Strong analytical skills for complex problem-solving.
• Judgment exercised within broad policies, with knowledge of technical alternatives and their business impact.