Job Description
**Manufacturing MES Specialist Role Summary**: Lead the deployment and support of Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data.
As a key member of the team, you will be responsible for leading the deployment and support of Manufacturing Execution Systems (MES), Manufacturing Batch Records (MBRs), Generic Manufacturing Batch Records (GMBRs) and Equipment data. Your typical day will involve reviewing and approving MES project deliverables, reviewing design specs, populating and completing review of MES documentation, leading pre-PE executions and testing of MES records, and coordinating team efforts on plant testing and documentation of all testing protocol.
- Review and approve MES project deliverables against the overall project plan
- Review MES Design Specs using MR/BS and completed design spec/process flow map templates
- Populate and complete review of MES documentation, including Config Spec (MESCS) and Trace Matrices (TMs)
- Lead Pre-PE executions (Static and Dynamic) and testing of MES records
- Coordinate team efforts on plant testing (Shakedowns) of MES documents with MFG SME
- Coordinate team efforts 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
This role is ideal for individuals with knowledge and experience of MES, preferably Werum PAS/X, who possess logical troubleshooting and problem-solving skills, excellent analytical, written and oral communication skills, and the 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.