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Process Engineer Lead - Sterilisation

  • Sector: Engineering
  • Contact Email:
  • Job Ref: 22250

An exciting opportunity for an experienced Process Engineer Lead to join a leading Life Science company based in their new manufacturing facility in Kilkenny on a permanent contract. As a Process Engineer lead you will be the Specialist in the Pharmaceutical/Biological Process Sterilisation Sub-Function, considered as highly experienced and knowledgeable resource within the organisation in implementing and maintaining pharmaceutical processes. You will also have the opportunity to travel to vendor locations for training in Europe and worldwide.

Role Responsibilities: (Full job description available on request)

  • The Process Engineer Lead will 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)

  • The Process Engineer Lead will 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 that all work conducted is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).

Role Requirements:

  • A relevant third level qualification in Engineering/Manufacturing/Science, Mechanical, Electrical, Electromechanical is preferred.

  • Minimum 5 years’ experience in the Engineering/Manufacturing/ Scientific field.

  • Demonstrate Leadership qualities are a distinct advantage.

For a confidential discussion and more information on the role, please contact Barry O'Brien.