Shift Manufacturing MES Specialist

1 month ago

Ireland Regeneron Pharmaceuticals, Inc Full time

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 Manufacturing MES Specialist a typical shift 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 0-2 years of experience working within a Life Sciences manufacturing environment or equivalent combination of education and experience.

#REGNIELSM #LI-Onsite #IRELIM #JOBSIEST #REGNIEEC

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels

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 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location. #J-18808-Ljbffr

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