Validation Engineer

About AbbottIn Ireland, Abbott employs over 5,000 people across nine sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.Abbott Ireland Nutrition Division Cootehill CavanAbbott 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.Primary Function / Goals / ObjectivesThe 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 to 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. This also involves the development and support of plant SME’s and general users.Participate in internal audits.Support all areas of QA as required, participate in plant projects as required.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.Support QA team with internal and external audits (including pre-audit preparation) surrounding the validation and approved consumables processes. Major ResponsibilitiesProvide 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.Education RequiredBachelor’s Degree in Pharmaceutical Science, Food Science, Dairy Science or related Engineering qualifications. Food Microbiology or Food Chemistry would be desirable however, not essential.KnowledgeIt 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 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.Accountability / ScopeThis function will have the responsibility to provide direction, documentation, execution and review for plant validation activities.