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MES Specialist, MBR Author
Location
Europe
Posted
148 days ago
Salary
0
Seniority
Senior
Job Description
MES Specialist, MBR Author
futureproof consulting
• Author, maintain, and sustain electronic Master Batch Records (MBRs) and Generic Master Batch Records (GMBRs) using Werum/Körber PAS-X • Ensure MES solutions are designed and implemented in compliance with cGMP regulations, SOPs, and global business processes • Execute change control and MBR lifecycle management activities to maintain system compliance and state of control • Collaborate with manufacturing sites to gather requirements and implement MBR/GMBR updates following defined lifecycle procedures • Support MES integrations with systems such as SAP, DCS, SCADA, Historian, and LIMS • Provide MES/EBR operational support, including troubleshooting and resolution of manufacturing issues • Work closely with Quality, Manufacturing, Automation, and IT teams to ensure quality-driven decisions • Support MES training, collaboration, benefit realization, and standardization initiatives • Identify and implement continuous process improvement opportunities • Perform validation-related activities using electronic validation tools such as Kneat eVal
Job Requirements
- Hands-on experience with MES (Werum/Körber PAS-X)
- Strong expertise in MBR and GMBR design and maintenance
- Minimum 5 years of experience in a regulated production environment (pharmaceutical, biotech, or similar)
- Strong understanding of manufacturing processes and principles (Biologics preferred)
- Ability to translate manufacturing requirements into automation and digital solutions
- Proven analytical skills with strong problem-solving ability and attention to detail
- Excellent written and verbal communication skills
- Experience working with global stakeholders across North America, Europe, and Asia
- High personal integrity, credibility, and accountability.
Benefits
- B2B contract
- Long-term cooperation on a global pharmaceutical project with high business visibility.
- Opportunity to work for a globally recognized pharmaceutical company with a strong digital focus.
- Engage in innovative, international projects that have real impact on healthcare.
- Remote in EU area.
- Collaborative, multicultural, and inclusive team culture.
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