MES Engineer

States considered:
Michigan

The MES Engineer is responsible for providing intermediate-level technical support, configuration, and continuous improvement of the site's Manufacturing Execution System (MES), primarily Korber/Werum PASX, within a regulated pharmaceutical manufacturing environment. This role ensures that MES records, processes, and system integrations are optimized for reliability, compliance, and operational efficiency. The Engineer will lead technical initiatives, system enhancements, and cross‑functional projects that improve MES and ERP functionality, user experience, and overall manufacturing performance.

• Design, configure, test, and deploy MES master batch records (MBRs), formulas, recipes, and business logic using object oriented concepts within PASX.
• Troubleshoot plant‑floor MES execution issues, interface failures, and system integration challenges between MES, ERP, and automation systems.
• Support daily MES operations, including deviation root‑cause investigation, corrective action implementation, and real‑time troubleshooting.

• Partner with the Software Systems Engineer and support integration between MES and Level 2 automation / control systems (e.g., SCADA/Ignition, OPC‑based connections).
• Support ERP‑to‑MES data flow health, identifying and resolving inefficiencies related to SAP S/4
  
  HANA and associated interfaces.

• Ensure MES maintains compliance with GMP, inspection readiness standards, and data integrity expectations.
• Author, execute, and manage change controls, validation protocols, and qualification documentation related to MES upgrades, enhancements, and system changes.
• Lead and author deviation investigations, applying root‑cause analysis tools (e.g., FMEA) to identify issues and implement sustainable corrective and preventative actions (CAPAs).
• Utilize systems such as Track Wise or Veeva Vault to manage deviations, CAPAs, and other GxP documentation.

• Drive annual Continuous Improvement (CI) projects, meeting or exceeding financial and performance targets aligned to job grade expectations.
• Leverage Power BI and related analytics tools to track, visualize, and communicate MES performance metrics, system health, and operational KPIs.
• Collaborate with manufacturing, quality, automation, supply chain, and IT teams to define system requirements and ensure process parameters are accurately captured and controlled in MES.

• Provide on‑floor and remote MES technical support to ensure right‑first‑time batch execution.
• Assist manufacturing operations with root‑cause analysis for MES or ERP‑related deviations, implementing timely and effective solutions.
• Occasional non‑routine or off‑shift support may be required based on production needs.

• Bachelor's degree in Computer Science, Engineering, Information Systems, or related technical discipline.
• 3+ years of MES experience, including configuration, troubleshooting, and solution design within Korber/Werum PASX, POMS, Rockwell Pharma Suite, or comparable life sciences MES platforms.
• Experience with SAP S/4
  
  HANA and strong understanding of ERP‑MES integrations.
• Knowledge of SCADA systems and industrial communication protocols (e.g., Ignition, OPC).
• Understanding of TCP/IP networking, routing, ports, and firewall concepts.
• Experience with Lean Six Sigma or continuous improvement methodologies.
• Basic statistical analysis skills for process troubleshooting and data evaluation.
• Previous experience in a GMP‑regulated pharmaceutical or life sciences environment preferred.
• Strong technical writing skills with the ability to communicate complex technical concepts to diverse stakeholders.
• Proficiency with Microsoft Office, Power BI, and comparable statistical or analytical tools.

The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable…