futureproof consulting

MES Specialist, MBR Author

futureproof consulting

contract

Posted on:

Location Type: Remote

Location: Anywhere in Europe

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About the role

  • 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

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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Master Batch Records (MBRs)Generic Master Batch Records (GMBRs)MES (Werum/Körber PAS-X)change controlMBR lifecycle managementmanufacturing process improvementvalidation activitieselectronic validation toolstroubleshootingautomation solutions
Soft Skills
analytical skillsproblem-solvingattention to detailcommunication skillscollaborationintegritycredibilityaccountability