Job Description :

Job summary:

The MES Senior MBR Modeler is responsible for leading the effort to translate a manufacturing process into a configured and tested MBR in an MES system.
Responsibilities:
• Map the manufacturing workflow which takes account of things such as the paper batch records, P&IDs, SOPs/Work Instructions, technology transfer reports, interfaces with other systems etc.
• Design of the MBR to accurately reflect the manufacturing process
• Identify the MBR elements necessary to build the MBR (e.g. production units, equipment, basic operations, basic functions etc). Identify the activities to be performed by each functional element (e.g. basic operations and basic functions).
• Design the material flow (e.g. identify where material is consumed and created in each operation).
• Identify the points of data exchange between MES and other systems (e.g. PCS, ERP, LIMS etc) and determine what data needs to be exchanged.
• Ensure the appropriate BOM is associated with the MBR.
• Run workshops with relevant stakeholders for purposes such as:
• Data gathering
• Business proving of MBRs
• Configuration of MBRs.
• Validation/testing of MBRs.
• As necessary, make modifications to existing MBRs under change control.
• Interface with all relevant stakeholders, e.g. operations, process engineering, quality, logistics, etc.
The Senior MBR Modeller attributes include:
• Business analyst/process modeling experience in the pharmaceutical/biopharmaceutical environment.
• Excellent communication skills (written, oral, and presentation).
Required skills: MBR design in MES Werum PAS X, Data exchange between MES and other systems, ISA-95
Years of exp: 5+ years design, analysis, integration of MES, preferably in Werum PAS-X
Hybrid role: Los Angeles County, CA (La Verne, CA)

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Samar
Samar(at)

             

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