Pharma MES Master Batch Record Designer (Remote)

GMP Pros, Inc.

Omaha (NE)

Remote

USD 90,000 - 130,000

Full time

14 days+

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Job summary

GMP Pros, Inc. seeks a Master Batch Record (MBR) Designer to develop, configure, and maintain electronic Master Batch Records within a MES to support compliant and efficient production for pharma, biotech, food, and animal health sectors.

The role offers remote work with occasional on-site collaboration and requires prior biotech/pharmaceutical industry experience. Applicants must have hands-on eBR design experience and knowledge of GMP and 21 CFR Part 11, with strong communication and

Qualifications

3–5 years of experience in pharmaceutical manufacturing, quality assurance, or technical writing with batch record exposure.
Minimum 2–3 years of hands-on design with electronic batch records (eBR) like PAS-X or similar.
GMP, FDA 21 CFR Part 11 and related regulatory standards familiarity.
Experience mapping business processes using Visio or Lucidchart.

Responsibilities

Collaborate with project teams to translate requirements for PAS-X deployment across Oral Solids production.
Translate design blueprints into GMBRs, MBRs, PMBRs, PVLs, and ESPs for deployment.
Assist in Master Data creation and management.
Support hardware/infrastructure integration (printers, scanners, clients).
Test and troubleshoot designs in the DEV environment and assist PROD validation.
Support Early Life Support and Hyper Care during deployment across site.
Maintain project deliverables and milestone dates.