Associate Manufacturing MES Specialist
Lead the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data.
Responsibilities:
* Review and approve MES project deliverables against the overall project plan
* Review MES Design Spec using MR/BS and completed design spec/process flow map templates
* Populate and complete review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs)
* Lead Pre-PE executions (Static and Dynamic) and testing of MES records
* Coordinate team on plant testing (Shakedowns) of MES documents with MFG SME
* Coordinate team and documentation of all testing protocol and ensure GDP and compliance
* Coordinate Workflows for documentation approval
* Review data for build of OPM recipes to support the MES build
* Coordinate MES Deployment Support – documentation readiness and change control support
* Coordinate with area owners to ensure Process Area readiness for MES Deployment (hardware, barcoding etc.)
* Coordinate sustaining deployed MES records to ensure timely close-out of executed MES records
* Lead MFG element of launch activities in the lead up to MES records live on the production floor
* Lead coordination of hypercare activities as part of wider MES team live on the production floor
Requirements:
* BS/BA/BEng in a technical discipline
* 0-2 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience
* Demonstrate knowledge and experience of MES preferably Werum PAS/X
* Logical troubleshooting and problem-solving skills
* Excellent analytical, written and oral communication skills
* Able to work within a successful team