Lead Validation Engineer

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 122,000 colleagues serve people in more than 160 countries.

Abbott in Ireland

Abbott has maintained a strong presence in Ireland since 1946 and celebrates its 80th anniversary in the country in 2026. The company supports the Irish healthcare sector with a broad portfolio spanning diagnostics, diabetes care, medical devices and nutritional products. Today, Abbott employs more than 6,200 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.

Please note any offer of employment for this position is conditional upon the successful completion of a pre-employment medical examination, including drug and alcohol screening, conducted by a medical practitioner designated by the Company.

We have an exciting opportunity as a Lead Validation role and this role will involve the following:

 Job Purpose

As the Lead Validation Engineer, you will act as a key Subject Matter Expert driving the site’s validation strategy. You will provide direction, documentation, execution, and oversight for all plant validation activities, ensuring compliance, robustness, and continuous improvement across the facility. You will work closely with the Validation Manager, lead critical QA functions, and champion the Plant Consumables Programme, making this a highly visible and influential role.

Key Responsibilities

• Serve as a core member of the QA Team, reporting to the Validation Manager.
• Manage the Validation Change Control System, Validation Master Plan, schedules, and all associated documentation.
• Lead the Validation Review Board, ensuring all members are trained and compliant with validation policies and procedures.
• Create, review, and approve validation protocols and full validation packages.
• Own and manage the Plant Consumables Programme, ensuring compliance and approval of all consumables.
• Support CAPA and Quality Metrics programmes.
• Conduct compliance audits, walk‑downs, and follow‑up reporting.
• Support QA IT systems (M‑Files), including training and developing plant SMEs and users.
• Participate in internal audits and support external audit readiness.
• Contribute to plant projects and cross‑functional initiatives as required.
• Adapt to changes in GMP, EHS, Technical, Quality, and SOP updates.
• Support QA during internal and external audits, including pre‑audit preparation.
• Follow all EHS rules, report hazards, and wear appropriate PPE.
• Review and adhere to all SOPs relevant to assigned tasks.

Education & Experience

• Bachelor’s degree in Pharmaceutical Science, Food Science, Dairy Science, Engineering, or a related discipline
• Minimum of 3 years’ experience in a Validation role within pharmaceutical, food, healthcare, or regulated manufacturing.
• Background in Food Microbiology or Food Chemistry is desirable but not essential.

Key Skills

• Strong knowledge of Validation processes, CAPA systems, and FDA/industry regulations.
• Advantageous experience in Food Engineering, thermal processing, and fluid flow.
• Understanding of manufacturing processes and project management principles.
• Excellent interpersonal skills, strong computer literacy, and the ability to work effectively in a high‑performance team.

Accountability / Scope

• Provide expert leadership in validation direction, documentation, execution, and review.
• Ensure validation activities meet regulatory, quality, and operational expectations.
• Maintain high standards of accuracy and compliance to protect product quality and plant performance.