Computer Systems Validation Engineer Apply
Location: Ireland - Kilkenny
Time Type: Full time
Posted On: Posted 3 Days Ago
Job Requisition ID: 31091185
JOB DESCRIPTION: Have you ever wanted to make a difference? At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.
Abbott Ireland In Ireland, Abbott employs around 6,000 people across ten sites. We currently have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott also has commercial, support operations and shared services in Dublin and Galway. We have been making a difference in the lives of Irish people since 1946.
Diabetes Care Kilkenny Our new manufacturing facility in Kilkenny, opening in 2024, reflects the growing demand for Abbott's global Diabetes Care products. The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
At Abbott in Kilkenny, you can shape your career as you help shape the future of healthcare.
This is how you can make a difference at Abbott: In this role you will be responsible for creating and implementing the Abbott Division validation program. Creating and maintaining validation documentation for new and existing systems and processes subject to design control. You will also ensure that validation activities are implemented for systems as per requirements and standards as listed in the Abbott's current Quality Systems Manual. You might also travel to vendor locations for training in Europe or the US. Previous experience in implementing software projects from greenfield stage.
ResponsibilitiesThe validation and operational management of computerized systems.The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.Maintaining the quality and compliance status of associated Procedures, work instructions.Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.Qualifications and ExperienceRelevant third level qualification. IT/Engineering/Manufacturing/Science is preferred.2-3 years working knowledge of software validation in the med devices industry.Experience carrying out Cyber security assessments.Experience working in a 21CFR820 and/or ISO13485 regulated industry. May consider experience in pharmaceutical validations.What we OfferAttractive compensation package that includes competitive pay, as well as benefits such as:
Family health insuranceExcellent pension schemeLife assuranceCareer DevelopmentFantastic new facilityGrowing business plus access to many more benefits.Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
Abbott is an equal opportunities employer.
The base pay for this position is N/A. In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:ADC Diabetes Care
LOCATION:Ireland > Kilkenny: Kilkenny Business and Technology Park
ADDITIONAL LOCATIONS:N/A
WORK SHIFT:Ie - Kkyflx (Ireland)
TRAVEL:Yes, 10% of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
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