Remote Master Batch Record Designer (GMP/MES)

GMP Pros, Inc.; United States; Híbrido; USD 90 000 - 130 000; Tempo integral

Resumo da oferta

GMP Pros, Inc. is seeking an MBR Designer to develop, configure, and maintain electronic Master Batch Records within a MES framework in a dynamic startup environment.

You will work with a project team to translate design blueprints into compliant MBRs and PMBRs for Oral Solids and packaging, ensuring GMP compliance. You will manage master data, support hardware integration, test in DEV and validate in PROD, and participate in Early Life Support and Hyper Care activities across sites.

Qualificações

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Industrial, Chemical, Mechanical, or Automation Engineering.
• 3–5 years in pharmaceutical manufacturing, QA, or technical writing with batch record exposure.
• 2–3 years hands-on design with electronic batch record systems (PAS-X preferred).
• Experience mapping business processes; FDA GMP and 21 CFR Part 11 knowledge.
• Experience in a project team within an FDA-regulated environment.

Responsabilidades

• Collaborate with project team to design and deploy PAS-X based MBRs, PMBRs, and related records.
• Translate design blueprints into GMP-compliant eBRs and ensure data integrity.
• Support creation and management of Master Data and hardware/infrastructure integration.
• Test designs with end users in DEV and verify in PROD environments.
• Support Early Life Care and milestone tracking; maintain deliverables.

Conhecimentos

Communication

Organization

Analytical thinking

Problem solving

Process mapping

Multi-tasking

Formação académica

Bachelor's degree in Life Sciences/Pharma/Industrial/Automation

PAS-X training/certification

Ferramentas

PAS-X

Visio

Lucidchart

Descrição da oferta de emprego

GMP Pros, Inc. is seeking an MBR Designer to develop, configure, and maintain electronic Master Batch Records within a MES framework in a dynamic startup environment.

You will work with a project team to translate design blueprints into compliant MBRs and PMBRs for Oral Solids and packaging, ensuring GMP compliance. You will manage master data, support hardware integration, test in DEV and validate in PROD, and participate in Early Life Support and Hyper Care activities across sites.