Associate Manufacturing MES Specialist
As an Associate Manufacturing MES Specialist, 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.
The role involves reviewing and approving sessions of MES project deliverables against the overall project plan. This includes reviewing MES Design Specs using the MR/BS and completed design spec/process flow map templates, populating and completing reviews of MES documentation such as Config Spec (MESCS) and Trace Matrices (TMs).
You will lead Pre-PE executions (Static and Dynamic) and testing of MES records, coordinate team on plant testing (Shakedowns) of MES documents with MFG SME, and ensure GDP and compliance. Additionally, you will coordinate workflows for documentation approval, review data for build of OPM recipes to support the MES build, and coordinate MES Deployment Support - documentation readiness and change control support.
This role requires coordination with area owners to ensure Process Area readiness for MES Deployment (hardware, barcoding etc.) and sustaining deployed MES records to ensure timely close-out of executed MES records. You will also lead MFG element of launch activities in the lead up to MES records live on the production floor and lead coordination of hypercare activities as part of wider MES team live on the production floor.
To be considered for this opportunity, you should 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, and demonstrate an ability to work within a successful team.
We are seeking a candidate with 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.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.