MES Deployment Lead for Life Sciences Manufacturing

Regeneron Pharmaceuticals, Inc.; Limerick; Presencial; EUR 37.000 - 75.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking an Associate Manufacturing MES Specialist to join our Manufacturing MES team.

This role focuses on deploying and supporting MES, including batch records and equipment data, to enable compliant manufacturing. You will lead MES design reviews, coordinate pre-PE testing, ensure GDP and regulatory compliance, and drive go-live activities on the production floor with timely close-out of records.

Formación

• BS/BA/BEng in a technical discipline.
• 0-2 years experience as Associate Specialist.
• Life sciences manufacturing experience is advantageous.

Responsabilidades

• Lead deployment and support of MES batch records (MBR/GMBR) and equipment data.
• Chair review sessions of MES deliverables against the project plan.
• Review MES design specs using MR/BS templates.
• Lead pre-PE executions and testing of MES records.
• Review data for building OPM recipes to support MES build.
• Coordinate plant testing (shakedowns) of MES docs and testing protocols with GDP compliance.
• Coordinate document approvals and change control for MES deployment.
• Coordinate with area owners to ensure Process Area readiness (hardware, barcoding).
• Sustain deployed MES records and ensure timely close-out of executed records.
• Lead go-live activities and hypercare on production floor.
• Supervise KPI data to aid wider MES/MFG team.

Conocimientos

MES

Batch records

GDP compliance

Data analysis

Project coordination

Educación

BS/BA/BEng in technical discipline

Herramientas

Werum PAS/X

Descripción del empleo

Regeneron Pharmaceuticals, Inc. in Raheen, Limerick is seeking an Associate Manufacturing MES Specialist to join our Manufacturing MES team.

This role focuses on deploying and supporting MES, including batch records and equipment data, to enable compliant manufacturing. You will lead MES design reviews, coordinate pre-PE testing, ensure GDP and regulatory compliance, and drive go-live activities on the production floor with timely close-out of records.