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 107,000 colleagues serve people in more than 160 countries.
Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.
Abbott Ireland Nutrition Division Cootehill Cavan
Abbott Nutrition produces a range of infant formulae in all pack sizes under the brand name “Similac”. To complement the range of “Similac” infant formulae, the facility also manufactures a range of follow on formulae under the brand name of “Gain”. The essential ingredient is liquid skim milk and this is combined with carbohydrate, vegetable oils, vitamins and minerals. The product is blended, pasteurised, dried and packaged at the site and once packaged, is distributed to Europe, South East Asia, the Middle East, Latin America and Canada.
Established in 1975, Abbott Nutrition in Ireland is the largest powder manufacturing facility for the production of infant formulae within the Abbott Corporation worldwide. Approximately 1,000 dairy farms in Ireland and Northern Ireland supply quality milk to the Cootehill facility which processes 500,000 litres per day. This secure supply together with Ireland’s reputation as a green, clean environment is of significant strategic importance to Abbott Nutrition.
PURPOSE OF THE JOB
To Provide direction, documentation, execution and review for plant validation activities. And work closely with the Engineering Project team. This function will have the responsibility to provide direction, documentation, execution and review for plant validation activities.
- Follow all Environmental, Health and Safety Rules and Regulations in the plant.
- Report any current or potential hazards to your manager immediately.
- Wear the correct Personal Protective Equipment (P.P.E.) at all times. Consult the appropriate SOP where required.
- This function has the responsibility for reviewing all SOP’s for any job task he/she may carry out and ensure he/she fully understands and adheres to the SOP.
- The Validation Engineer will be part of the Engineering Team reporting to the Capital Business Office Engineer.
- Manage and co-ordinate the Validation Change Control System, Validation Master Plan and associated schedule and all related documentation.
- Participate in the Validation Review Board, ensuring they are trained in accordance to Validation Policies and Procedures.
- Responsible for the creation of validation packages and review of all validation protocols and packages.
- SME for the QA IT Systems (M-FILES) through which Validation Change Control is documented.
- This Job function will change where update procedures to GMP, EHS, Technical / New Equipment, Quality Procedures & SOP’s are made.
- This list of responsibilities may change depending on plant needs and employees are expected to be adaptable and flexible were this need arises.
EDUCATION & COMPETENCIES
- Bachelor’s Degree in Pharmaceutical Science, Food Science, Dairy Science or related Engineering qualifications. Food Microbiology or Food Chemistry would be desirable however, not essential.
- It is an advantage to have knowledge on Validation and/or FDA regulations in relation to validation.
- Food Engineering, thermal heat processing and fluid flow are advantageous.
- Knowledge of Validation 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.
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