GMP Pros, Inc. logo
GMP Pros, Inc.1 week ago

Master Batch Record (MBR) Designer - 1099/W2

Hybrid · Omaha, Nebraska, United States

Type
Contract
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

MBR Designer responsibilities include designing, configuring, and maintaining electronic Master Batch Records within a MES to support compliant and efficient production for biotech/pharma/animal health clients. You will translate design blueprints into MBRs/PMBRs/PVLs/ESPs, manage Master Data, integrate hardware/infrastructure, test designs in DEV PROD environments, support Early Life Support and Hyper Care, and ensure deliverables meet GMP/regulatory standards. Requires collaboration within project teams, strong communication, and the ability to multi-task across multiple projects. A Bachelor’s degree in a relevant life sciences or engineering field and 3-5 years in pharma/biotech/animal health contexts with hands-on eBR design experience are required.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering, or a related technical field
  • 3-5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing with exposure to batch record development
  • 2-3 years of hands-on design experience with electronic batch record (eBR) systems such as PAS-X, Pharmasuite, Siemens opCenter, etc. (PAS-X preferred)
  • Knowledge of GMP, FDA 21 CFR Part 11, and other relevant regulatory standards
  • Experience mapping business processes (e.g. Visio or Lucid Chart)
  • Experience working in a project environment with a project team
  • Pre-Employment: background check, safety certification, drug screen
Sorce

Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.

Hiring someone like this?

Get your role in front of qualified candidates on Sorce.

Get started

GMP Pros, Inc.

Master Batch Record (MBR) Designer - 1099/W2

Apply on Sorce