
Systems Integration Expert
2 weeks ago
We are seeking an experienced Manufacturing Systems Designer to join our team in the development of Master Batch Records and improvement of the MES business process.
Key Responsibilities:- Develop, configure, and test Master Batch Records from initial to final design.
- Lead MBR development design reviews, liaising with Operations, Process Development, and Quality functions.
- Draft, execute, and review Application Lifecycle Management test scripts and test sets for testing MBR design.
- Support and ongoing development of the client's MES system in development of MBRs and improving the MES business process.
- Train Electronic Batch Record end-users on EBR operation and maintenance.
- Develop, review, and update MES Standard Operating Procedures.
Requirements:
- Strong experience within a similar MES designer/MES Specialist/Manufacturing Specialist role within a pharmaceutical/biotech industry.
- Experience developing, configuring, and testing of Master Batch Records (MBRs).
- Knowledge of regulation requirements (GMP & EH&S).
- Experience with PAS-X.
- Ability and drive to learn quickly and work as part of a team.
- Aseptic Fill/Finish manufacturing environment experience highly desirable.
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