Job Summary
This role involves leading the deployment and support of Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs), and Equipment data.
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
Education and Experience
A BS/BA/BEng in a technical discipline, with 0-2 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience is required.