Specialist Mbr Author

Merck & Co., Inc.

Rahway, NJ, USA
Hybrid
Werum/korber pas-x electronic master batch records
Cgmp regulations and sops
Mes system state of control and compliance
The MES Specialist acts as a subject matter expert responsible for the successful and compliant design, development, deployment, and support of Werum/Korber PAS-X electronic Master Batch Records

Job Summary

  • The MES Specialist acts as a subject matter expert responsible for the successful and compliant design, development, deployment, and support of Werum/Korber PAS-X electronic Master Batch Records.
  • Key responsibilities include identifying continuous process improvement opportunities, sustaining electronic Master Batch Records, and executing change control processes to ensure system compliance.
  • The role requires collaboration and assistance with troubleshooting manufacturing problems, providing MES support to ongoing Electronic Batch Record operations, and ensuring knowledge of Quality Systems and Regulatory Standards.

Matching Summary

The MES Specialist acts as a subject matter expert responsible for the successful and compliant design, development, deployment, and support of Werum/Korber PAS-X electronic Master Batch Records.

Skills & Requirements

Must-have

  • Werum/Korber PAS-X electronic Master Batch Records
  • cGMP regulations and SOPs
  • MES system state of control and compliance
  • troubleshooting MES manufacturing problems
  • Quality Systems and Regulatory Standards knowledge

Nice-to-have

  • continuous process improvement opportunities
  • analytical skills and problem solving
  • excellent communication and influencing skills
  • strong written and verbal communication

Key Requirements

  • Bachelor’s Degree and 4+ years MES support experience
  • 6+ years relevant MES experience
  • Minimum three (3) years regulated industry experience
  • Direct experience with MES (PAS-X)
  • Strong experience in MBR, GMBR design

Work Rights

Not specified

Tailored Resume

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