About Us
At Abbott, we are a global healthcare leader dedicated to helping people live more fully at all stages of life.
We have a diverse portfolio of life-changing technologies spanning the spectrum of healthcare, including diagnostics, medical devices, nutritional and branded generic medicines.
Our 109,000 colleagues serve people in over 160 countries worldwide.
A Global Presence in Ireland
Abbott serves the Irish market with a wide range of healthcare products, including diagnostics, medical devices, and nutritional products.
In Ireland, we employ around 6,000 people across ten sites.
We have manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford, Kilkenny, and Sligo, as well as a third-party manufacturing management operation in Sligo.
Absolutely Shared services and commercial operations are based in Dublin and Galway.
A History in Ireland
Abbott has been operating in Ireland since 1946.
Diabetes Care Division
The Abbott Diabetes Care division, based in Donegal Town, manufactures FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management.
Our leading brands include the FreeStyle Precision, FreeStyle Lite, and FreeStyle Libre system.
Role Summary
This role is an individual contributor position requiring comprehensive knowledge in Microbiology and cleanroom environments.
The successful candidate will have the ability to execute complex or specialized projects.
Main Responsibilities
Key Accountabilities:
* Manage and maintain the site Environmental Monitoring program, ensuring compliance with regulatory requirements and minimizing product bioburden & endotoxin levels.
* Coordinate Environmental monitoring activities, including microbiological service suppliers.
* Evaluate and validate cleanrooms, ensuring compliance with internal requirements and applicable regulations and standards.
* Analyze product quality and process data using statistical techniques to identify trends and implement improvement plans.
* Lead validation activities within the Microbiology area and provide facility and operations departments with microbiological support.
* Ensure regulatory requirements are met and maintained, including FDA, GMP, and ISO requirements.
* Serve as a Microbiology/Cleanroom Subject Matter Expert during internal and external audits and address microbiology-related observations and CAPA's/QR's.
Requirements
Essential Qualifications:
* Relevant third-level Degree in Science or equivalent.
* Minimum 3 years' experience in Science or equivalent.
* Prior experience with ISO cleanrooms, bioburden testing, and endotoxin testing is preferred.