About Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Our 113,000 colleagues serve people in more than 160 countries.
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Abbott In Ireland
We have been operating in Ireland since 1946. We employ over 6,000 people across ten sites in Ireland. Six manufacturing facilities are located in Clonmel, Cootehill, Donegal, Longford, and Sligo, while commercial, support operations, and shared services are based in Dublin and Galway.
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Abbott Nutrition Division Cootehill Cavan
Abbott Nutrition produces Similac infant formulae under the brand name "Similac". To complement the range of "Similac" infant formulae, we manufacture follow-on formulae under the brand name of "Gain". Our facility combines liquid skim milk with carbohydrate, vegetable oils, vitamins, and minerals to create our products.
The product is blended, pasteurised, dried, and packaged at the site and once packaged, it is distributed to Europe, South East Asia, the Middle East, Latin America, and Canada.
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Primary Function / Goals / Objectives
- The Lead Validation Engineer will be part of the QA Team reporting to the Validation Manager.
* Manage and co-ordinate the Validation Change Control System, Validation Master Plan, and associated schedule and all related documentation.
* Lead the Validation Review Board, responsible for ensuring all VRB members are trained in accordance with Validation Policies and Procedures.
* Responsible for the creation of validation packages and review of all validation protocols and packages.
* Responsible for the management of the plant consumables program.
* Support the CAPA and Quality Metrics programme as required.
* Conduct compliance audits and walk-downs and complete necessary follow-up reports.
* Support QA IT Systems (M-FILES) through which Validation Change Control is documented.
* Participate in internal audits.
* Support all areas of QA as required, participate in plant projects as required.
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Major Responsibilities
- Provide direction, documentation, execution, and review for plant validation activities.
Work closely with the Validation Manager.
Provide leadership across a number of QA functions including Validation and the Plant Consumables Programme.
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Knowledge, Skills, Experience:
- Bachelor's Degree in Pharmaceutical Science, Food Science, Dairy Science or related Engineering qualifications.
Food Microbiology or Food Chemistry would be desirable but is not essential.
It is an advantage to have knowledge on Validation and CAPA Policies or FDA regulations in relation to validation.
Food Engineering, thermal heat processing, and fluid flow are advantageous.
Knowledge of Validation is preferred.
Project Management Skills or experience with Project Management is essential.
Excellent interpersonal skills and very good computer literacy.
Ability to work as an effective member of a high-performance team.