MES Specialist / MBR Author

This is a remote position.

Key Responsibilities

• 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
  

• Knowledge of SAP integration
  
• Experience with Level 2 systems (Historian, SCADA, DCS) and their integration with PAS-X
  
• Familiarity with electronic validation tools (e.g. Kneat eVal)
  

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.