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Senior Manufacturing Systems Engineer

3 weeks ago

Dublin, Dublin City, Ireland beBeeMes Full time €60,000 - €90,000

As a MES Designer, you will play a pivotal role in the development and configuration of Master Batch Records (MBRs) from initial to final design.

The ideal candidate will have strong experience within a similar MES designer / MES Specialist / Manufacturing Specialist role within a pharmaceutical / biotech industry.

You will be responsible for leading MBR development design reviews including liaising with Operations, Process Development and Quality functions.

Additionally, you will be responsible for drafting, executing and reviewing Application Lifecycle Management test scripts and test sets for testing MBR design.

Your expertise will be utilized in the support and ongoing development of the Client's MES system in development of MBRs and improving the MES business process.

Furthermore, you will be responsible for training of Electronic Batch Record (EBR) end-users (Supervisors, Operators, Technical/QA/Support staff).

An added responsibility will be the development, review and update of MES Standard Operating Procedures.

The successful candidate will possess strong knowledge of regulation requirements (GMP & EH&S), as well as experience developing, configuring and testing of Master Batch Records (MBRs).

PAS-X experience is highly desirable.

With aseptic fill / finish manufacturing environment experience, you will be an asset to our team.

This is an exciting opportunity to join a globally recognised pioneer in Biotechnology and contribute to their mission to better the lives of those affected by disease and illness.

We are seeking a dedicated and driven individual who can work effectively as part of a team and demonstrate ability to learn quickly.

  • Key Responsibilities
  • Develop, configure and test Master Batch Records (MBRs)
  • Lead MBR development design reviews
  • Draft, execute and review Application Lifecycle Management test scripts and test sets
  • Support and develop the Client's MES system
  • Train Electronic Batch Record (EBR) end-users
  • Develop, review and update MES Standard Operating Procedures