US_East | Manufacturing & Process Engineer_L

Digital Engineer – MES/Opstrakker & Werum Client-X

Location:

Raritan, NJ

The role involves supporting and implementing Werum Client-X and manufacturing operations platforms such as Ops Trakker across life sciences, pharmaceutical, biotech, and regulated manufacturing environments. The focus is on enabling operational excellence, electronic batch execution, manufacturing visibility, and regulatory compliance.

• 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, and integration services.
  • Support deployment and ongoing enhancement of Ops Trakker 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 hyper‑care 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 Ops Trakker application issues and perform root‑cause analysis.
  • 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, and support documentation.
  • Participate in Agile delivery teams and collaborate across global stakeholders.

• Education:
  
  Bachelor’s Degree in Engineering, Computer Science, Manufacturing Engineering, Information Systems, or a related technical discipline.
• Experience:
  
  5–7 years in Manufacturing IT, MES, or Digital Manufacturing; 3+ years hands‑on experience with Werum Client‑X; experience supporting manufacturing operations platforms such as Ops Trakker; experience working within GMP‑regulated environments.
• Werum Client‑X Proficiency: M /E  development and maintenance, Client‑X configuration and modeling, user management and security concepts, material and equipment management, process order execution, and Client‑X troubleshooting and support.
• Integration Technologies: ERP integration (SAP preferred), LIMS integration, Web services/API concepts, SQL and relational databases, and manufacturing data interfaces.

• 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, and Pharma Suite.
• Experience with Power BI or manufacturing analytics tools.
• Experience working in cloud or hybrid manufacturing environments.
• Agile/Scrum delivery experience.