What are the responsibilities and job description for the MES Lead position at JC Automation?
Company Overview
JC Automation is a global management and technology consulting firm dedicated to empowering organizations across industries. We specialize in delivering cutting-edge solutions in IT, automation, and regulatory compliance, supporting clients from manufacturing shop floors to enterprise-level systems. Our expert teams provide ongoing management and support to ensure seamless system operations.
Position Overview
The MES Lead – Werum PAS-X will serve as the site technical and functional lead for the Manufacturing Execution System at the Wilson, NC manufacturing facility. This role is responsible for ensuring reliable, compliant, and efficient execution of PAS-X to support commercial pharmaceutical manufacturing operations.
The MES Lead will partner closely with Manufacturing, Quality, MSAT, IT, Automation, and Global Digital teams to ensure system performance, regulatory compliance, and alignment with global standards and quality systems.
Key Responsibilities
- Serve as the primary site SME for Werum PAS-X and provide end-to-end MES lifecycle ownership (design, build, deploy, sustain).
- Ensure alignment with global MES standards and digital strategy.
- Lead configuration and maintenance of Master Batch Records (MBRs), equipment models, material definitions, electronic workflows, and weigh & dispense operations.
- Support new product introductions (NPI), product transfers, and process improvements.
- Ensure compliance with FDA / EMA regulations, 21 CFR Part 11, GxP, and Data Integrity (ALCOA ).
- Lead or support validation deliverables including URS, FS, DS, RTM, IQ/OQ/PQ.
- Support internal and external regulatory inspections and audit trail reviews.
- Support integration between PAS-X and SAP/ERP, LIMS, and automation systems (DeltaV / PLCs).
- Provide MES operational support for commercial manufacturing activities.
- Troubleshoot production issues and lead root cause investigations.
- Drive right-first-time improvements, cycle time reduction, and continuous improvement initiatives.
- Manage change control, deviation support, and CAPA activities related to MES.
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, Information Systems, or related discipline.
- 7 years of experience in pharmaceutical or biotech manufacturing environments.
- 5 years of hands-on Werum PAS-X configuration and support experience.
- Strong knowledge of GMP, 21 CFR Part 11, and data integrity requirements.
- Experience supporting FDA inspections.
- Strong cross-functional collaboration and communication skills.
Preferred Qualifications
- Experience in a large global pharmaceutical organization.
- Experience working within global MES templates.
- Knowledge of DeltaV or other automation platforms.
- Experience supporting commercial-scale manufacturing.
- Lean / Six Sigma exposure.
Job Type: Full-time
Pay: $75.00 - $95.00 per hour
Work Location: In person
Salary : $75 - $95