Associate Manufacturing MES Specialist

2 weeks ago


Dublin, Dublin City, Ireland Regeneron 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 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.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.#J-18808-Ljbffr

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