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 Dosimetry Laboratory Supervisor to join our New Abbott Diabetes Care Kilkenny site. The following is required for this role:

Responsible for supervising the operation of the ebeam sterilisation dosimetry laboratory. Responsible for maintaining the effectiveness of the site dosimetry monitoring program in accordance with GLP, GMP and regulatory requirements.  Ensuring CAPA activities are followed through to completion. Provide direction and technical expertise to dosimetry laboratory personnel and to the site. Provide leadership during problem solving situations related to dosimetry issues.

MAJOR RESPONSIBILITIES

• Provide product and manufacturing support in a cGMP regulatory environment.
• Supervise, develop, and mentor employees within the team.
• Develop and drive the site dosimetry program, updating as appropriate.
• Manage and co-ordinate all the dosimetry lab activities, including coordination with 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 dosimetry lab methods, equipment 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 results, to ensure accuracy of data and timely communication of results.
• Ensure dosimetry lab is validated and controlled and comply with internal requirements, applicable regulations and ISO11137 standards.
• Provide technical guidance and support, in the areas of dosimetric release methods, dose mapping procedures and dosimetry curve calibration.
• Lead problem solving efforts related to dosimetric release 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 four years’ work experience in a Manufacturing / Science / Quality or equivalent environment.
• Electron beam or other sterilisation technologies experience desirable.
• Knowledge in ISO 11137 desirable.
• Chemistry/Microbiology/Dosimetry Lab experience desirable.

     

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:

     

WORK SHIFT:

Ie - Kkyhr84 (Ireland)

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable