Master Batch Record (MBR) Designer - 1099/W2
Hybrid · Omaha, Nebraska, United States
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
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