Jobs · Information Technology · North Carolina

Manufacturing Execution Systems (MES) SME

Pinnaql · Wilson, NC · 1 mo ago
On-siteInformation TechnologyFull-time

About the role

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Manufacturing Execution Systems (MES) SME. 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. At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team. Excited to build something meaningful together? We look forward to hearing from you.

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.

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