Contractor MES EBR Expert

Experienced engineer for major Consumer Products client, supporting major MES and EBR systems.

Role:

Crucial role in design, implementation, and maintenance of MES and EBR systems.

Responsibilities:

• Leading or assisting in UAT process (test plan creation, execution, issue resolution)
• Supporting validation of MES/EBR systems against business/regulatory standards
• Training end-users on MES/EBR systems, operational and compliance aspects
• In-depth understanding of manufacturing processes, especially regulated industries (pharmaceuticals, chemicals, biotech)
• Knowledge of GMP regulations (FDA 21 CFR Part 11, 210, 211)
• 7-10+ years experience managing electronic batch records in Life Sciences, ensuring accurate capture/review/storage in EBR systems
• Translating business requirements into functional specifications
• Working with stakeholders (production, quality assurance, regulatory) to define system requirements
• Mapping current processes, identifying system/process gaps & inefficiencies
• Expertise in specific MES platforms (Ignition/Sepasoft, Siemens Opcenter, Rockwell FactoryTalk)
• Deep understanding of EBR systems (document control, Batch/Recipe Management, record-keeping, approval workflows, MES integration)
• Familiarity with system integration (ERP, LIMS, PLC, SCADA, other enterprise systems) and integration tools (MQ, SOAP, RESTful API)

Qualifications

• Bachelor's Degree in Engineering, Computer Science, or equivalent.

Location: Remote US-based, occasional international travel possible.

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