MES Engineer Werum PAS-X (Core 3)

We are seeking an experienced MES Engineer with strong expertise in Werum PAS-X and Core 3 configuration to support the delivery enhancement and support of MES solutions within a regulated pharmaceutical/biotech manufacturing environment.

The successful candidate will work closely with manufacturing quality validation and automation teams to design and implement robust MES solutions that support electronic batch records process execution and digital manufacturing initiatives.

Key Responsibilities

• Design configure and support Werum PAS-X MES solutions within GMP manufacturing environments
  
• Develop and maintain PAS-X Core 3 functionalities including:
  • Master Batch Records (MBRs)
    
  • Electronic Batch Records (EBRs)
    
  • Workflow configuration
    
  • Materials and resource management
    
  • Process parameter integration
    
• Collaborate with cross-functional stakeholders including Manufacturing QA Validation Automation and IT
  
• Support MES deployment activities including commissioning qualification and validation
  
• Execute testing activities including FAT SAT IQ/OQ support and user acceptance testing
  
• Troubleshoot MES issues and provide ongoing operational support
  
• Participate in change control deviation investigations and CAPA activities
  
• Ensure compliance with GMP GAMP5 and 21 CFR Part 11 requirements
  
• Support integration activities between MES and adjacent systems such as SAP LIMS DeltaV or SCADA platforms
  
• Create and maintain technical and functional documentation
  

Required Experience

• Bachelors degree in Engineering Computer Science Life Sciences or related discipline
  
• Strong hands-on experience with Werum PAS-X MES
  
• Proven experience working with PAS-X Core 3
  
• Experience in pharmaceutical or biotech manufacturing environments
  
• Strong understanding of GMP-regulated systems and validation lifecycle
  
• Experience with electronic batch record design and execution
  
• Familiarity with ISA-95 concepts and manufacturing process integration
  
• Experience supporting commissioning and qualification activities
  
• Excellent problem-solving and stakeholder communication skills
  

Preferred Experience

• Experience with PAS-X upgrades or greenfield MES deployments
  
• Knowledge of integration technologies and interfaces
  
• Experience with SAP integration
  
• Familiarity with serialization recipe management or automation systems
  
• Exposure to DeltaV Siemens Rockwell or other automation platforms