egulated pharmaceutical manufacturing environments.
The candidate will be responsible for designing, configuring, validating, and supporting electronic Master Batch Records (MBRs/GMBRs/PMBRs) within the Werum PAS-X MES platform. The role involves collaborating with QA, Process Engineering, Automation, and Manufacturing teams to ensure compliance with pharmaceutical industry standards and regulatory requirements.
Professionals should have experience in MES integration with SAP ERP systems, L2/L3 automation systems, serialization platforms, and pharmaceutical manufacturing processes. Strong knowledge of GMP, GAMP 5, CFR Part 11, data integrity, and validation methodologies is highly preferred.
The role also includes troubleshooting MES and MBR-related issues, supporting MES implementation activities, and contributing to process standardization and harmonization initiatives across manufacturing sites. Candidates should possess excellent analytical, communication, and documentation skills with the ability to work in highly regulated pharmaceutical environments.
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