Process Engineer Lead Sterilisation

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:

In this role you will be the Specialist in the Pharmaceutical/Biological Process Sterilisation Sub-Function, considered as highly experienced and knowledgeable resource within the organization in implementing and maintaining pharmaceutical processes. You will also have the opportunity to travel to vendor locations for training in Europe and worldwide.

As a Process Engineer Lead in e-beam Sterilisation you will be required to:

• Provide product and manufacturing support in a cGMP regulatory environment.
• As part of a cross functional team liaise with equipment suppliers and perform and manage equipment installations. (SAT/FAT)
• Monitor machine performance (OEE/KPI's) in real time to maximise production output.
• Contribute to analytical development through design and execution of experiments, data analysis and communication of conclusions through presentations and reports.
• Coordinate and contribute to the design of Ops, protocols, specifications, and validation documentation (IQ/OQ/PQ).
• Develop and drive the site sterilisation program, updating as appropriate.
• Supervise in implementing and maintaining the sterilisation processes for the site.
• Manage and co-ordinate all sterilisation activities, including coordination with providers and suppliers.
• Model processes and unit's operations.
• Write documentation for sterilisation process flow, support equipment validation and provide guidance and feedback.
• Ensure equipment maintains its validated state.
• Ensure that all work conducted is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
• Drive the sterilisation training program, knowing safety rules and regulations, and making sure all personal are trained on safe work practices.
• Seek opportunities for significant, process or product improvements, considering critical quality attributes, critical process parameters, and product performance characteristics.
• Develop and maintain project timelines and provide updates and feedback to leadership.
• Data management, trending (including SPC) and reporting of product performance and other business measures.
• With appropriate training become a subject matter expert in process & product.
• Service, troubleshoot and solves engineering problems with processes or equipment already in operation.
• Ensures processes and procedures are in compliance with regulations.
• Initiate and complete CAPAs and Change Controls in accordance with site procedures.
• Liaise with key business stakeholders; QA, Manufacturing, Engineering, R&D, Regulatory Affairs and Purchasing to ensure timely completion of activities.
• Excellent communication / interpersonal skills
• Proven Technical writing skills with proven capability in providing rationale for equipment and processes.
• Mentor coach and co-ordinate a team

Qualification & Experience

• A relevant third level qualification in Engineering/Manufacturing/Science, Mechanical, Electrical, Electromechanical is preferred.
• Minimum 5 years' experience in the Engineering/Manufacturing/ Scientific field.
• Ability to interpret data, discuss findings and resolve complex analytical problems.
• Recognize adverse trends and emerging issues. Propose and implement solutions to internal and external issues.
• Strong problem solving.
• Strong mechanical and electrical ability with computer experience, MS excel, and word are essential
• Computer statistical skills will provide immediate expertise for the trending and reporting of data
• Must possess good organizational skills and attention to detail
• Demonstrate Leadership qualities are a distinct advantage
• Demonstrated flexible and innovative approach to work
• Electron beam, Gamma, or other sterilisation technologies experience desirable.
• Knowledge in ISO 11137 desirable.
• Travel 15%

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Abbott is an equal opportunities employer.