This is a remote position.

OUr pharmaceutical client is looking for an experienced MES Specialist / MBR Author to support the design, development, maintenance, and continuous improvement of electronic Master Batch Records (eMBRs) within the Werum/Körber PAS-X Manufacturing Execution System (MES).

You will act as the subject matter expert responsible for authoring, updating, validating, and supporting electronic batch records while ensuring compliance with GxP, cGMP, and global quality standards. Working closely with Manufacturing, Quality, Automation, and Digital teams across North America, Europe, and Singapore, you will help standardize manufacturing processes and enable efficient digital manufacturing operations.

This is an excellent opportunity for professionals with strong MES/PAS-X, MBR/GMBR, and pharmaceutical manufacturing experience who enjoy bridging manufacturing operations with digital technologies.

Key Responsibilities

MES / Electronic Batch Record Development

• Design, author, configure, and maintain electronic Master Batch Records (MBRs) using Werum/Körber PAS-X
  
• Configure and maintain Generic Master Batch Records (GMBRs) following global standards
  
• Translate manufacturing processes into compliant electronic workflows
  
• Support deployment of new MES functionalities and enhancements
  

Manufacturing Support

• Provide day-to-day MES support for production operations
  
• Troubleshoot manufacturing and Electronic Batch Record (EBR) issues
  
• Collaborate with manufacturing sites to resolve production-related MES problems
  
• Support batch execution and ensure smooth MES operations
  

Change Management & Compliance

• Execute MES change controls throughout the MBR lifecycle
  
• Ensure compliance with:
  • cGMP
    
  • GxP
    
  • SOPs
    
  • Global manufacturing standards
    
• Maintain MES systems in a validated and compliant state
  
• Support validation activities using Kneat eVal (or similar validation tools)
  

Integration & Digital Manufacturing

• Update and maintain MES integrations with:
  • SAP
    
  • DCS
    
  • SCADA
    
  • Historian
    
  • LIMS
    
• Collaborate with Automation and Digital teams on MES integration initiatives
  
• Support digital manufacturing transformation projects
  

Continuous Improvement

• Identify opportunities to optimize manufacturing processes
  
• Improve standardization of electronic batch records
  
• Support MES governance and best practices
  
• Contribute to global MES process improvements
  

Collaboration & Training

• Partner with Manufacturing, Quality, Validation, and Engineering teams globally
  
• Support end-user MES training and knowledge sharing
  
• Work with site SMEs to understand manufacturing requirements
  
• Participate in global MES community initiatives​
  

Requirements

• Bachelor's Degree in Engineering, Computer Science, Life Sciences, or a related field
  
• Language: Spanish
  
• 5+ years of experience supporting Manufacturing Execution Systems (MES)
  
• Strong hands-on experience with Werum/Körber PAS-X
  
• Extensive experience authoring and maintaining:
  • Electronic Master Batch Records (MBRs)
    
  • Generic Master Batch Records (GMBRs)
    
• Experience working within regulated pharmaceutical, biotechnology, or life sciences environments
  
• Strong understanding of:
  • Manufacturing processes
    
  • cGMP
    
  • GxP
    
  • Batch manufacturing
    
  • Electronic Batch Records (EBR)
    
• Experience managing MES lifecycle activities and change control
  
• Strong analytical, troubleshooting, and problem-solving skills
  
• Excellent communication and stakeholder management skills
  
• Ability to collaborate with global teams across multiple regions
  

Preferred Qualifications

• Experience with SAP integration
  
• Experience integrating PAS-X with:
  • DCS
    
  • SCADA
    
  • Historian
    
  • LIMS
    
• Experience with Kneat eVal or similar electronic validation platforms
  
• Knowledge of biologics manufacturing processes
  
• Experience with automation and digital manufacturing initiatives
  
• Spanish language proficiency
  
• Experience supporting global pharmaceutical manufacturing sites
  

Technical Environment

Manufacturing Execution Systems

• Werum / Körber PAS-X
  
• Electronic Batch Records (EBR)
  
• Master Batch Records (MBR)
  
• Generic Master Batch Records (GMBR)
  

Enterprise Systems

• SAP
  
• LIMS
  

Automation Systems

• DCS
  
• SCADA
  
• Historian
  

Validation & Compliance

• Kneat eVal
  
• cGMP
  
• GxP
  
• SOPs
  
• Change Control
  
• Validation Lifecycle
  

Benefits

• Location: Remote in Europe
  
• Contract Type: Freelance / Contract
  
• Start date: June/July, 2026
  
• Time Allocation: 40 hours/week
  
• Global Pharmaceutical Company in Prague