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 over 5,000 people across nine 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 that enable 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:
We currently have a requirement for a Microbiologist to join our New Abbott Diabetes Care Kilkenny site. The following is required for this role:
Responsible for developing and managing the site microbiology program. Responsible for maintaining the effectiveness of the site environmental monitoring program and product release testing in accordance with GLP, GMP and regulatory requirements. Ensuring CAPA activities are followed through to completion. Provide technical expertise to laboratory personnel and to the site. Provide leadership during problem solving situations related to microbial issues.
MAJOR RESPONSIBILITIES
Provide product and manufacturing microbial support in a cGMP regulatory environment.
Develop and drive the site microbiology program, updating as appropriate.
Manage and co-ordinate testing activities, including microbiological service providers and suppliers.
Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
Write documentation for test methods, cleanroom qualifications and equipment validation and provide guidance and feedback.
Support laboratory set-up and maintenance of laboratory equipment and consumables.
Drive the laboratory training program, knowing safety rules and regulations, and making sure all personal are trained on safe work practices.
Review laboratory test results, to ensure accuracy of data and timely communication of results.
Perform environmental monitoring sampling of controlled cleanroom areas as required.
Ensure cleanrooms are validated and controlled and comply with internal requirements, applicable regulations and ISO14644 class 8 standards.
Provide technical guidance and support, in the areas of microbiological methods, cleanroom behaviours and cleanroom environmental monitoring.
Support problem solving efforts related to microbial issues and provide technical advice as required.
Support unplanned events and raise out of specification results in a timely manner.
Initiate and complete CAPAs and Change Controls in accordance with site procedures.
Analyse product quality and process data using statistical techniques to identify trends and implement improvement plans accordingly. Generate and present quarterly and annual reports.
Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.
EDUCATION & EXPERIENCE
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:
Medical & Scientific Affairs
DIVISION:
ADC Diabetes Care
LOCATION:
Ireland > Kilkenny : Kilkenny Business and Technology Park
ADDITIONAL LOCATIONS:
WORK SHIFT:
Ie - Shftpre0 (Ireland)
TRAVEL:
Yes, 20 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable