Within this role you will be responsible for leading the deployment and support of the Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data.
As an Associate Manufacturing MES Specialist a typical shift might include, but is not limited to, the following:
1. Reviewing and approving sessions of MES project deliverables against the overall project plan
2. MES Design Spec reviewing using the MR/BS and completed design spec/process flow map templates
3. Populating and completing review of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs)
4. Leading Pre-PE executions (Static and Dynamic) and testing of MES records
5. Coordinating team on plant testing (Shakedowns) of MES documents with MFG SME
6. Coordinating team and documentation of all testing protocol and ensure GDP and compliance
7. Coordinating of Workflows for documentation approval
8. Reviewing of data for build of OPM recipes to support the MES build
9. Coordinating of MES Deployment Support – documentation readiness and change control support
10. Coordinating with area owners to ensure Process Area readiness for MES Deployment (hardware, barcoding etc.)
11. Coordinating of sustaining deployed MES records to ensure timely close-out of executed MES records
12. Leading MFG element of launch activities in the lead up to MES records live on the production floor
13. Leading coordination of hypercare activities as part of wider MES team live on the production floor
This role might be for you if:
1. You demonstrate knowledge and experience of MES preferably Werum PAS/X
2. You possess logical troubleshooting and problem-solving skills
3. You have excellent analytical, written and oral communication skills
4. You demonstrate an ability to work within a successful team
To be considered for this opportunity you should have 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.
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