Manufacturing MES Specialist
This role is responsible for leading the deployment and support of Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs), and Equipment data.
Key Responsibilities:
* Reviewing and approving sessions of MES project deliverables against the overall project plan
* MES Design Spec reviewing using the MR/BS and completed design spec/process flow map templates
* Populating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs)
* Leading Pre-PE executions (Static and Dynamic) and testing of MES records
* Coordinating team on plant testing (Shakedowns) of MES documents with MFG SME
* Coordinating team and documentation of all testing protocol and ensure GDP and compliance
* Coordinating of Workflows for documentation approval
* Reviewing of data for build of OPM recipes to support the MES build
* Coordinating of MES Deployment Support - documentation readiness and change control support
* Coordinating with area owners to ensure Process Area readiness for MES Deployment (hardware, barcoding etc.)
* Coordinating of sustaining deployed MES records to ensure timely close-out of executed MES records
* Leading MFG element of launch activities in the lead up to MES records live on the production floor
* Leading coordination of hypercare activities as part of wider MES team live on the production floor
Requirements:
* Demonstrate knowledge and experience of MES preferably Werum PAS/X
* Possess logical troubleshooting and problem-solving skills
* Have excellent analytical, written and oral communication skills
* Demonstrate an ability to work within a successful team
Qualifications:
* 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