JOB DESCRIPTION :
Abbott serves the Irish market with a diverse range of health care products including diagnostics, medical devices and nutritional products.
In Ireland, Abbott employs almost 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, 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
In Donegal we are currently going through an expansion as we introduce new technology and equipment to manufacture the Libre Freestyle Sensor which is groundbreaking in the management of Diabetes.
As part of the expansion we have a requirement for a Quality / Validation Engineer
We are seeking a Quality / Validation Engineer to implement and maintain the effectiveness of the Quality Systems, ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance.
Responsibilities include :
You will review and approve all documentation where required specific to Qualification / Validation activities for Computer System Validation, Manufacturing and Test Equipment Validation, Process Validation and Facilities validation.
You will ensure any investigations / deviations associated with the validation activities are deeply investigated and closed in a timely manner.
As the Quality / Validation Engineer you will oversee the Software Change Management Process.
You will be responsible for site Software Configuration Management.
You will play a key role in ensuring that the Quality Management System is fully implemented and effective.
You will develop a deep understanding in the site validation and calibration programme.
In the role you will write & approve Standard Operating Procedures as required.
You will also work with the manufacturing departments to assist in maintaining quality in production.
An essential element of the role is to ensure compliance with applicable Corporate and Divisional Policies while also performing other duties as assigned by the leadership team.
Education and Experience Required
Third level Science / Engineering or Manufacturing qualification with three years experience in a similar work environment.
Strong experience of Computer System Validation regulations in line with 21 CFR Part 11, Annex 11 is needed.
Act as an authority in validation within the Quality area.
Knowledge and understanding of EU and US cGMP regulations with respect to the validation, production and testing of Medical Devices.
Clearly, demonstrated proficiency in Technical writing, in English.
Proficient with word processing (MS Word), power point and spreadsheets (Excel).
Good social skills, ability to influence and effectively communicate to all levels in the organisation.
Abbott is an equal opportunities employer.