Validation Engineer

About Abbott

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott in Ireland

In Ireland, Abbott employs more than 3,200 people across 11 sites. Abbott has six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. It has commercial operations in Dublin and shared services in Dublin and Westport. Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices, nutritionals and branded generic pharmaceuticals. Abbott has been operating in Ireland since 1946. 

Abbott Ireland Nutrition Division – Cootehill

Abbott Nutrition in Cootehill manufactures infant nutritional products for the export markets.  The facility is dedicated to providing products of the highest quality standard to its customers.

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”.

Primary Function / Goals / Objectives

• 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.
• The Validation Engineer will be part of the QA Team reporting to the CAPA & 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 Responsibilities

• Provide direction, documentation, execution and review for plant validation activities.
• Work closely with the CAPA and 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.
• 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 / Scope

• This function will have the responsibility to provide direction, documentation, execution and review for plant validation activities. 

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