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Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Associate Manufacturing MES Specialist

Enterprise ApplicationsConfirmed live in the last 24 hours
Full-timeLimerick, Ireland€37k - €75.4k /yr

About the Job

Requirements

  • Knowledge and experience of Manufacturing Execution Systems (MES), preferably Werum PAS/X.
  • Logical troubleshooting and problem-solving skills.
  • Excellent analytical, written, and oral communication skills.
  • A bachelor's degree (BS, BA, or BEng) in a technical discipline is required.
  • Associate Specialist experience of 0–2 years.
  • Experience working within a life sciences manufacturing environment is advantageous.

Responsibilities

  • Lead deployment and support of Manufacturing Execution Systems (MES) manufacturing batch records (MBRs), generic manufacturing batch records (GMBRs), and equipment data.
  • Chair review and approval sessions of MES project deliverables against the overall project plan.
  • Review MES design specifications using MR/BS and completed design specification/process flow map templates.
  • Lead pre-PE executions (static and dynamic) and testing of MES records.
  • Review data for building OPM recipes to support the MES build.
  • Coordinate plant testing (shakedowns) of MES documents, testing protocols, and ensure good documentation practice (GDP) and compliance.
  • Coordinate workflows for documentation approval, MES deployment support, documentation readiness, and change control support.
  • Coordinate with area owners to ensure process areas are ready for MES deployment, including hardware and barcoding.
  • Coordinate sustaining deployed MES records to ensure timely close-out of executed MES records.
  • Lead the manufacturing element of go-live activities leading up to MES records going live on the production floor, and ensure hypercare activities.
  • Supervise KPI data to help the wider MES/manufacturing team drive consistency and timeliness.

Desired Qualifications

  • Experience working within a life sciences manufacturing environment.

About the Company

Regeneron Pharmaceuticals

Develops biopharmaceutical therapies for serious diseases

Regeneron Pharmaceuticals develops and commercializes medicines for serious diseases, with a focus on cancer, eye diseases, allergic and inflammatory diseases, and infectious diseases. Its products come from using proprietary research capabilities and technologies to discover and develop therapies, often in collaboration with academic, research, and industry partners. Revenue comes from selling approved medicines and from licensing its technologies and entering co-development and co-commercialization partnerships. The company works with healthcare providers and regulators to ensure treatment delivery and safety. Its goal is to improve patient outcomes by bringing life-transforming medicines to market through rigorous R&D and strategic collaborations, maintaining leadership in biopharmaceutical innovation.

Company size
10,001+
Company stage
IPO
Headquarters
Town of Mount Pleasant, New York
Founded
1988

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