**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 the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. **Abbott in Ireland** Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo. **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. **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 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. + 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. **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. **Education Required** + 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. **Knowledge** + 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. + Very good Knowledge of the Validation process. + An understanding of the manufacturing process. + Project Management Skills or experience with Project Management is preferred. + Excellent interpersonal skills and very good computer literacy. + Ability to work as an effective member of a high performance team. **Accountability / Scope** + This function will have the responsibility to provide direction, documentation, execution and review for plant validation activities. **Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** Abbott in Ireland | Benefits (https://www.ie.abbott/careers/benefits.html) Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com