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, nutritionals 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:
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
• Third level Science / Manufacturing or equivalent qualification.
• Minimum three years’ work experience in a Manufacturing / Science / Quality or equivalent environment.
Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.
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 - Kkyhrflx (Ireland)
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
Top Skills
What We Do
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, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
