Process Engineer Lead – Sterilisation

Role Summary:

• A fantastic vacancy has arisen for a Sterilisation Process Engineer Lead to join our client’s new manufacturing facility in Co. Kilkenny.
• 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.

Core Duties and Responsibilities:

• 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.

Minimum Qualifications and 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 & 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% of time

Please note, we do not require agency assistance with this role.