Digital Engineer - MES/Opstrakker & Werum

Saicon Consultants, Inc.

• $110K — $130K *
Raritan, NJ 08869In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Engineering, Computer Science, Manufacturing Engineering, Information Systems, or related technical discipline
  • 5-7 years of experience in Manufacturing IT, MES, or Digital Manufacturing
  • 3 years of hands-on experience with Werum Client-X
  • Experience in supporting manufacturing operations platforms like OpsTrakker
  • Familiarity with GMP regulated environments

Responsibilities

  • Configure, develop, and support Werum Client-X solutions
  • Support deployment and enhancement of OpsTrakker
  • Analyze business requirements for functional MES solutions
  • Integrate MES solutions with ERP and shop floor applications
  • Troubleshoot and resolve Client-X and OpsTrakker application issues
  • Create and maintain functional specifications and training materials
  • Participate in Agile delivery teams and coordinate with global stakeholders

Benefits

  • Dynamic work environment with opportunities for continuous improvement
  • Collaboration across global teams
  • Support for professional development and training
  • Access to state-of-the-art technology and manufacturing processes
  • Engagement in cross-functional projects to enhance skill sets
Full Job Description
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.
* Ladders Estimates

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