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, nutritional and branded generic medicines. With over 107,000 colleagues, we serve people in more than 160 countries.
In Ireland, Abbott employs over 4,000 people across nine sites, including manufacturing facilities in Clonmel, Cootehill, Donegal, Longford, and Sligo, along with support operations in Dublin and Galway. Operating since 1946, Abbott Ireland offers a diverse range of healthcare products.
Abbott Ireland Nutrition Division Cootehill Cavan
Our facility produces infant formulae under the brand 'Similac' and follow-on formulae 'Gain'. The plant processes liquid skim-milk combined with carbohydrates, vegetable oils, vitamins, and minerals, which are blended, pasteurized, dried, and packaged for distribution worldwide.
Established in 1975, our Ireland facility is the largest infant formula powder manufacturer within Abbott globally, sourcing milk from approximately 1,000 Irish and Northern Irish farms, processing 500,000 liters daily.
The Role
We are seeking a Validation Engineer to support the Packing Department Projects division. You will assist Project Engineers in implementing improvements, integrating new products or processes, and ensuring validation activities comply with regulatory and company standards. You will report directly to the Packing Principal Programme Manager.
Major Responsibilities
* Create and review validation protocols and packages related to assigned projects.
* Utilize QA IT Systems (M-FILES) for documenting Validation Change Control.
* Provide guidance, documentation, execution, and review of validation activities.
* Develop validation documentation throughout project lifecycle, including during the FEP process.
* Collaborate with Validation and Manufacturing Teams and project equipment vendors to specify requirements.
* Ensure compliance with Abbott policies, quality, efficiency, and budget goals.
* Maintain knowledge of Validation and CAPA Policies or FDA regulations related to validation.
Primary Function / Goals / Objectives
* Support plant capital projects and assist Senior Project Engineers with documentation development.
* Develop and execute validation protocols (FAT, DQ, IQ, OQ, PQ).
* Manage change controls and project-related Quality issues and CAPAs.
* Attend validation review meetings and coordinate with internal and external stakeholders to ensure compliance and effective project execution.
* Maintain validation documentation and ensure adherence to GMP, safety, and environmental standards.
* Promote good employee relations and support Business Excellence initiatives.
Education Required
·Bachelor’s Degree in Engineering or equivalent.
Technical / Business Knowledge
* At least 3 years of relevant engineering experience.
* Understanding of automated manufacturing environments and packing equipment is advantageous.
* Strong problem-solving skills and logical thinking.
Accountability / Scope
* Requires careful attention to prevent equipment damage and ensure production targets are met.
* Failure to exercise due care could lead to losses or damage, and environmental non-compliance could result in legal issues.
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