- Manufacturing Execution Systems (MES) SME
This is a remote opportunity with 50% travel to Wilson, NC. The ideal candidate will bring strong experience with MES platforms and integrated manufacturing systems, with particular expertise in PAS-X, DeltaV, and SAP within a regulated GMP environment.
Key Responsibilities
- Serve as the MES Subject Matter Expert supporting manufacturing operations and digital manufacturing initiatives.
- Provide technical leadership for MES configuration, implementation, optimization, troubleshooting, and lifecycle support.
- Support integration and data flow between PAS-X, DeltaV, SAP, and associated manufacturing systems.
- Partner with Manufacturing, Automation, Engineering, Quality, IT/OT, and Validation teams to ensure reliable and compliant system performance.
- Support electronic batch records, master batch record configuration, manufacturing workflows, recipes, and system interfaces.
- Lead or support system changes, upgrades, testing, commissioning, qualification, and validation activities.
- Troubleshoot complex MES and system-integration issues and drive root-cause resolution.
- Ensure solutions comply with GMP, data integrity, computerized system validation, and applicable regulatory requirements.
- Develop and maintain technical documentation, procedures, specifications, and system lifecycle documentation.
- Provide technical guidance and mentorship to project and site teams.
Qualifications
- Bachelor's degree in Engineering, Computer Science, Automation, Information Systems, or a related technical discipline.
- Demonstrated experience supporting MES in pharmaceutical, biotechnology, or other regulated manufacturing environments.
- Strong hands-on knowledge of Werum/Körber PAS-X.
- Experience with Emerson DeltaV and SAP integrations in a manufacturing environment.
- Strong understanding of electronic batch records, manufacturing workflows, automation integration, and production systems.
- Experience supporting GMP computerized systems, commissioning/qualification, validation, change control, deviations, and system lifecycle activities.
- Strong troubleshooting, communication, and cross-functional collaboration skills.
- Experience integrating MES, automation, and enterprise systems in complex pharmaceutical manufacturing environments is highly preferred.
