Senior MES Engineer: Lead GMP Solutions & Practice

Orise

Raleigh (NC)

Sur place

USD 120 000 - 160 000

Plein temps

14 jours+

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Résumé du poste

Orise is seeking a Senior MES Engineer to expand our Manufacturing Execution Systems practice and provide on-site engineering support for pharmaceutical manufacturing in the RTP area. You will lead MES design, configuration, and deployment, acting as a technical SME for MES platforms while collaborating with production, quality, and IT stakeholders.

The role covers MES lifecycle activities from requirements gathering through deployment and support, including change management, investigations,

Qualifications

Bachelor’s degree in Engineering, Computer Science, Information Systems, or a related technical discipline.
7+ years of experience supporting or implementing MES solutions in pharmaceutical, biotech, or life sciences manufacturing environments.
Strong knowledge of GMP regulations, data integrity principles, and validated systems.
Hands-on experience with MES platforms (e.g., Emerson Syncade, Rockwell PharmaSuite, Körber PAS-X or similar).
Experience with MES configuration, integration, and support across manufacturing operations.
Strong troubleshooting, analytical, and problem-solving skills.
Ability to work effectively in an on-site, client-facing role.
Excellent written and verbal communication skills.

Responsabilités

Provide on-site and remote MES engineering support for pharmaceutical manufacturing operations in GMP environments.
Lead the design, configuration, and deployment of MES solutions in GMP-regulated environments.
Serve as a technical subject matter expert for MES platforms, supporting production, quality, and IT stakeholders.
Support MES lifecycle activities including requirements gathering, system configuration, testing, validation, deployment, and operational support.
Lead or contribute to change management, impact assessments, and controlled system updates.
Support investigations, root cause analysis, and issue resolution related to MES applications.
Lead, mentor, and grow a team of MES engineers, providing hands-on technical guidance, career development support, and day-to-day leadership to build a strong and scalable MES practice.
Drive the continued growth of the MES practice by defining standards, establishing best practices, and providing technical leadership to ensure consistent, high-quality MES solution delivery.
Collaborate closely with Sales and Business Development to support pre-sales activities, shape MES solutions, and identify new opportunities that expand the MES practice and overall business.