Digital Engineer - MES/Opstrakker & Werum

Key Responsibilities

• MES & Manufacturing Operations Delivery
  • Configure, develop, and support Werum Client-X solutions including:
    • Master Batch Records (MBRs)
    • Electronic Batch Records (EBRs)
    • Process workflows
    • Equipment and material management
    • Integration services
  • Support deployment and ongoing enhancement of OpsTrakker manufacturing operations and performance management solutions.
  • Analyze manufacturing business requirements and translate them into functional and technical MES solutions.
  • Participate in MES implementation projects through requirements gathering, design, configuration, testing, deployment, and hypercare support.
• Manufacturing Operations Integration
  • Integrate MES solutions with ERP, LIMS, historians, automation systems, and shop floor applications.
  • Support ISA-88 and ISA-95 aligned manufacturing architecture and data flows.
  • Collaborate with production, quality, engineering, and validation teams to streamline manufacturing processes.
• Support & Continuous Improvement
  • Troubleshoot Client-X and OpsTrakker application issues.
  • Perform root cause analysis and implement corrective actions.
  • Support production releases, upgrades, and change management activities.
  • Identify opportunities for process optimization, automation, and efficiency improvements.
• Documentation & Collaboration
  • Create and maintain:
    • Functional specifications
    • Design documents
    • SOPs
    • Training materials
    • Support documentation
  • Participate in Agile delivery teams and collaborate across global stakeholders.

Mandatory Skills and Skill Proficiencies

• Education
  • Bachelor's Degree in:
    • Engineering
    • Computer Science
    • Manufacturing Engineering
    • Information Systems
    • Related Technical Discipline
• Experience
  • 5–7 years of experience in Manufacturing IT, MES, or Digital Manufacturing.
  • 3 years of hands-on experience with Werum Client-X.
  • Experience supporting manufacturing operations platforms such as OpsTrakker, production tracking, or operational performance management solutions.
  • Experience working within GMP regulated environments.
• Werum Client-X
  • MBR/EBR development and maintenance
  • Client-X configuration and modeling
  • User management and security concepts
  • Material and equipment management
  • Process order execution
  • Client-X troubleshooting and support
• Integration Technologies
  • ERP integration (SAP preferred)
  • LIMS integration
  • Web services/API concepts
  • SQL and relational databases
  • Manufacturing data interfaces

Optional Skills and Skill Proficiencies

• Experience with pharmaceutical or biotech manufacturing.
• Knowledge of ISA-88 and ISA-95 standards.
• Experience with other MES platforms such as:
  • Syncade
  • Opcenter Execution Pharma
  • PharmaSuite
• Experience with Power BI or manufacturing analytics tools.
• Experience working in cloud or hybrid manufacturing environments.
• Agile/Scrum delivery experience.