| Location | Melrose Park, IL |
| Job Type | Contractor |
| Salary | $58–$62 Per Hour |
We are seeking an experienced MES PAS-X Engineer to provide hands-on production support within a pharmaceutical manufacturing environment in Melrose Park, IL. The engineer will work closely with Operations, Manufacturing, Quality, Engineering, Automation, and IT teams to troubleshoot and resolve Werum PAS-X MES issues impacting manufacturing operations.
This role is primarily focused on real-time MES production support, troubleshooting, issue resolution, user support, and system reliability in a highly regulated GMP/cGMP environment. The ideal candidate will have strong hands-on experience with Werum PAS-X, Electronic Batch Records (EBR), MES integrations, production troubleshooting, and GMP computerized systems.
The selected candidate must be comfortable working the 10:00 PM–6:00 AM night shift and providing timely support for production-critical MES issues.
Provide hands-on production support for Werum PAS-X MES during the 10:00 PM–6:00 AM night shift.
Work directly with Manufacturing and Operations teams to troubleshoot and resolve MES issues affecting production.
Troubleshoot PAS-X transactions, workflows, electronic batch records, recipes, master data, equipment interfaces, and production orders.
Investigate and resolve MES application errors, transaction failures, system issues, and user-reported problems.
Support production operators with MES navigation, batch execution, material movements, electronic records, and manufacturing transactions.
Analyze application logs, error messages, system behavior, and integration failures to determine root causes.
Troubleshoot MES-to-equipment and MES-to-automation interfaces, including communication and data-transfer issues.
Support PAS-X configuration, master data, workflows, recipes, EBRs, and manufacturing processes.
Collaborate with IT, Automation, Engineering, Quality, and application support teams to resolve complex or escalated issues.
Document incidents, troubleshooting activities, root cause, corrective actions, and resolutions according to site procedures.
Support deviations, CAPA, change controls, investigations, and corrective actions associated with MES issues.
Ensure all MES support activities comply with GMP/cGMP, FDA regulations, 21 CFR Part 11, data integrity, and site SOPs.
Participate in MES testing, validation, upgrades, patches, releases, and controlled system changes.
Support UAT, regression testing, and system verification for PAS-X enhancements and changes.
Monitor recurring production issues and recommend improvements to MES reliability and manufacturing processes.
Provide timely escalation and communication for production-critical incidents during overnight operations.
Maintain technical documentation, troubleshooting procedures, knowledge articles, and support guides.
Bachelor's degree in Computer Science, Engineering, Information Technology, Automation, Manufacturing Systems, or a related technical discipline.
5+ years of experience supporting MES or manufacturing computerized systems.
3+ years of hands-on experience with Werum PAS-X MES strongly preferred.
Experience supporting pharmaceutical or biopharmaceutical manufacturing operations.
Hands-on experience supporting MES production issues in a real-time manufacturing environment.
Experience working directly with manufacturing operators, production supervisors, and Operations teams.
Strong understanding of Electronic Batch Records (EBR) and electronic manufacturing execution.
Experience with PAS-X workflows, recipes, master data, production orders, materials, equipment, and batch execution.
Experience troubleshooting MES integrations with automation, equipment, ERP, LIMS, or other manufacturing systems.
Experience working in a GMP/cGMP-regulated environment.
Understanding of FDA 21 CFR Part 11, electronic records/electronic signatures, GxP, and data integrity.
Experience with change control, deviations, CAPA, SOPs, validation, and controlled system changes.
Strong troubleshooting, analytical, communication, and root-cause-analysis skills.
Ability and willingness to work 10:00 PM–6:00 AM onsite.