JOB DESCRIPTION:
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, nutritional's and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Abbott in Ireland
Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.
Abbott Diabetes Care Kilkenny
Abbott Diabetes Care has opened a new site, in Kilkenny, that is at the forefront of Diabetes care with the latest technology, to manufacture Freestyle blood glucose test strips and Freestyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the Freestyle Precision, Freestyle Lite and Freestyle Libre systems.
This is how you can make a difference at Abbott:
As a Software Validation Engineer you will be involved in site Validation activities, primarily focusing on Software Validation with a secondary focus on Process and/or Equipment Qualifications.
Responsibilities:
- Define software validation strategy for specific projects in alignment with corporate procedures and
- Draft or collaborate on software project validation pre-requisites such as validation plans, 21 CFR Part 11 assessments, software risk assessments and requirement traceability matrices,
- Generates and executes validation protocols and associated reports for Software Validation Activities and technical reports related to equipment, products and/or processes.
- Provide necessary documentation and support during internal and external audits.
- Offer technical support and guidance on system requirements and validation processes as required
Education and Experience
- NFQ Level 7 Qualification in Engineering/Science or Equivalent
- 3 Years experience in a similar environment
- Project management experience, ability to work to pre-agreed schedules and report on progress to management.
- Lead investigations into validation anomalies or deviations and apply problem solving methodologies to arrive at and implement corrective actions.
- May assist with establishing corporate validation policies.
- Strong understanding of GAMP5 and regulatory requirements
What we Offer
Attractive compensation package that includes competitive pay, as well as benefits such as
- Family health insurance,
- Excellent pension scheme
- Life assurance
- Career Development
- Fantastic new facility
- Growing business plus access to many more benefits.
Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.
Abbott is an equal opportunities employer.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Engineering
DIVISION:
ADC Diabetes Care
LOCATION:
Ireland > Kilkenny : Kilkenny Business and Technology Park
ADDITIONAL LOCATIONS:
WORK SHIFT:
Ie - Kkyflx (Ireland)
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
