US_East | Manufacturing & Process Engineer_L4

Expedite Talent Solutions; Bloomfield (NJ); On-site; USD 110,000 - 140,000; Full time

Job summary

Expedite Talent Solutions seeks a Digital Engineer to support and implement Werum Client‑X and OpsTrakker in Raritan, NJ. You will configure and support MES solutions, align ISA‑88/ISA‑95 architectures, and collaborate with QA, IT, and manufacturing teams to enable operational excellence.

The role focuses on manufacturing visibility, electronic batch execution, regulatory compliance, and continuous improvement through system integration with ERP/LIMS and data interfaces, while participating in

Qualifications

• Must have 5–7 years in Manufacturing IT, MES, or Digital Manufacturing.
• Hands-on experience with Werum Client‑X including MBR/EBR development and maintenance.
• Experience supporting OpsTrakker or similar manufacturing operations platforms.
• Experience in GMP‑regulated environments and ISA‑88/ISA‑95 aligned data flows.

Responsibilities

• Configure, develop, and support Werum Client‑X solutions including MBRs/EBRs, workflows, and equipment/material management.
• Support deployment and enhancements of OpsTrakker manufacturing operations solutions.
• Translate manufacturing requirements into functional/technical MES designs and configurations.
• Participate in MES projects from requirements gathering to testing, deployment, and hyper‑care.

Skills

MES

OpsTrakker

Werum Client-X

GMP compliance

Agile delivery

Education

Bachelor’s Degree in Engineering, Computer Science, Manufacturing Engineering, Information Systems, or a related technical discipline

Tools

SAP integration

LIMS integration

SQL

Web services/API

Relational databases

Power BI

Job description

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 OpsTrakker across life sciences, pharmaceutical, biotech, and regulated manufacturing environments. The focus is on enabling operational excellence, electronic batch execution, manufacturing visibility, and regulatory compliance.

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, and 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 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 OpsTrakker 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.

Qualifications

• 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 OpsTrakker; experience working within GMP‑regulated environments.
• Werum Client‑X Proficiency: MBR/EBR 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.

Optional Skills

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