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futureproof consulting

Data, analytics and cybersecurity staffing. We connect professionals and companies to deliver successful projects.

MES Specialist, MBR Author

Product MarketingProduct MarketingContractRemoteSeniorTeam 1-10Since 2015H1B No SponsorCompany SiteLinkedIn

Location

Europe

Posted

148 days ago

Salary

0

Seniority

Senior

Bachelor Degree5 yrs expEnglish

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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