Senior Manufacturing MES Specialist
Job Details
Full Job Description
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 a Senior Manufacturing MES Specialist a typical day might include, but is not limited to, the following:
Chair review and approval sessions of MES project deliverables against the overall project plan
MES Design Spec review using the 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
Coordination of Workflows for documentation approval
Review of data for build of OPM recipes to support the MES build
Coordination of MES Deployment Support – documentation readiness and change control support
Coordination with area owners to ensure Process Area readiness for MES Deployment (hardware, barcoding etc.)
Coordination of 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 might be for you if:
You demonstrate knowledge and experience of MES preferably Werum PAS/X
You possess logical troubleshooting and problem-solving skills
You have excellent analytical, written and oral communication skills
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 5 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience.
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Regeneron is an equal
opportunity employer and all qualified applicants will receive
consideration for employment without regard to race, color, religion
or belief (or lack thereof), sex, nationality, national or ethnic
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information, familial status, marital or registered civil partnership
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will ensure that individuals with disabilities are provided reasonable
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contact us to discuss any accommodations you think you may need.