Remote Master Batch Record Designer (PAS-X Expert)

GMP Pros®; Omaha (NE); Hybrid; USD 90,000 - 130,000; Full time

Job summary

GMP Pros® seeks an experienced MBR Designer to develop and maintain electronic Master Batch Records (MBRs) within a MES, enabling compliant and efficient production. You will join a startup that supports top pharmaceutical, biotech, food, and animal health players.

Ideal candidates have 3–5 years in pharma, hands-on eBR design experience (PAS-X preferred), and strong regulatory knowledge. Remote work with occasional on-site collaboration is available.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 3–5 years in pharma manufacturing, QA, or technical writing.
• 2–3 years designing electronic batch records (eBR) such as PAS-X.
• Experience mapping business processes with Visio or Lucidchart.
• Knowledge of GMP and 21 CFR Part 11 requirements.
• Experience in FDA-regulated environments and cross‑functional teams.

Responsibilities

• Work with project teams to design and deploy PAS-X across manufacturing.
• Translate design blueprints into GMBRs, MBRs, PMBRs, PVLs, and ESPs.
• Support creation and management of Master Data.
• Assist integration of hardware and infrastructure (printers, scanners).
• Test designs with end users in DEV and PROD environments.
• Support verification, validation, and deployment activities site-wide.
• Maintain project deliverables and milestone dates.

Skills

MBR Design

Regulatory knowledge

Documentation

Process mapping

Education

Bachelor's degree in Life Sciences

Tools

PAS-X

Pharmasuite

Siemens OpCenter

Job description

GMP Pros® seeks an experienced MBR Designer to develop and maintain electronic Master Batch Records (MBRs) within a MES, enabling compliant and efficient production. You will join a startup that supports top pharmaceutical, biotech, food, and animal health players.

Ideal candidates have 3–5 years in pharma, hands-on eBR design experience (PAS-X preferred), and strong regulatory knowledge. Remote work with occasional on-site collaboration is available.