Abbott Validation Engineer in Cootehill, Ireland

JOB DESCRIPTION:

Abbott in Ireland

In Ireland, Abbott employs almost 3,000 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 and support 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.

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.

  • 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.

  • Food Safety Team Member conduct compliance audits and walk-downs and complete necessary follow-up reports.

  • 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.

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. Supervisory/Management Responsibilities

None

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.

JOB FAMILY:

Operations Quality

DIVISION:

ANSC Nutrition Supply Chain

LOCATION:

Ireland > Cootehill : Dromore West

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 38.0Hst0 (Ireland)

TRAVEL:

No

MEDICAL SURVEILLANCE:

Yes

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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