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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.
Abbott serves the Irish market with a diverse range of healthcare products, including diagnostics, medical devices, and nutritional products. In Ireland, Abbott employs over 6,000 people across ten sites. We have seven manufacturing facilities located in Clonmel, Cootehill, Donegal, Kilkenny, 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, Southeast 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.
The Role
As a Validation Engineer you will work within the Packing Department Projects division supporting a team of Project Engineers in the delivery of improvements to help integrate new products or processes into the existing manufacturing area, through the creation of documents and execution of validation work in compliance with current regulatory and company requirements. The successful candidate will report directly to the Packing Principal Programme Manager.
Major Responsibilities
• Provide direction, documentation, execution and review for project validation activities.
• Develop project validation documentation during the FEP process and throughout the lifecycle of projects.
• Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects
• Ensure compliance with Abbott policies and procedures, adherence to quality and efficiency goals and departmental budget performance.
Primary Function / Goals / Objectives
• Responsible for supporting plant capital projects as assigned.
• Support Snr Project Engineers with the development of project documentation. • Development and execution of validation protocols (FAT, DQ, IQ, OQ PQ).
• Execution of change controls.
• Management of any project associated Quality issues and CAPA’s.
• Work closely with Snr Project Engineers to ensure the work being undertaken is correctly documented in advance and the validation implications have been considered.
• Attend weekly Validation Review meetings with other engineers from around the site and the Quality/Validation Manager to ensure co-ordination of effort and minimising of unforeseen impacts.
• Liaise with internal engineering project co-ordination team, consultants, subcontractors, supervisors and the general workforce involved in the project to ensure full compliance with solution requirements.
• Responsible for the creation of validation packages and review of all validation protocols and packages related to assigned projects
• Utilise QA IT Systems (M-FILES) through which Validation Change Control is documented.
• Provide direction, documentation, execution and review for project validation activities.
• Develop project validation documentation during the FEP process and throughout the lifecycle of projects.
• Work closely with the Validation and Manufacturing Team.
• Work closely with project equipment vendors to obtain information to successfully specify requirements for plant and facility.
• Ensure compliance with Abbott policies and procedures, adherence to quality and efficiency goals and departmental budget performance.
• It is a requirement to have experience and knowledge on Validation and CAPA Policies or FDA regulations in relation to validation.
• Flexible with a can-do attitude
• Follow all Health and Safety Rules and Regulations in the plant
• Maintain plant safety at the highest level with a zero-accident target and with immediate response and thorough investigation and corrective action for all hazardous occurrences and accidents.
• It is important that GMP is a main priority in any operation carried out in this job function.
• Establish communication lines with all other departments e.g. Manufacturing, Q.A., Materials, Human Resources, Technical Operation Support and Finance.
• Plan and schedule work in accordance with plant demand and available manpower.
• Ensure compliance with Company International Global Standards, GMP & Environmental requirements.
• Responsible for promoting good employee relations.
• This job function will change where update procedures to GMP, EHS, Technical/New Equipment, Quality procedures and SOPs are made.
• Support Business Excellence initiatives in the plant.
Education Required
• Bachelor’s Degree in Engineering or equivalent discipline.
Technical / Business Knowledge
• Minimum of 3 years relevant experience in Engineering.
• Knowledge of an Automated Manufacturing Environment (understanding of packing equipment a distinct advantage).
• Good mental ability to logically follow a line of though for problem solving. Accountability / Scope
• Considerable and continual care and attention is needed to avoid substantial damage to equipment.
• Continual attention needed to ensure plant reaches its annual production plan. • Failure on the incumbent part not to exercise due care could cause repeated small losses or occasional damage.
• Environmental non-compliance will result in EPA/Legal censorship.
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