Senior MES Engineer

Orise; Raleigh (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Orise seeks a Senior MES Engineer to lead MES design, configuration, and deployment for pharmaceutical manufacturing in GMP environments. The role focuses on delivering MES solutions that improve efficiency, data integrity, and regulatory compliance, while mentoring a growing MES team and expanding the MES practice.

You will provide on-site and remote engineering support, collaborate with production, quality, and IT, and drive lifecycle activities from requirements through deployment.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field.
• 7+ years of MES experience in pharma, biotech, or life sciences environments.
• Strong knowledge of GMP, data integrity, and validated systems.
• Hands-on experience with MES platforms (e.g., Emerson Syncade, Rockwell PharmaSuite, Körber PAS‑X).
• Experience with MES configuration, integration, and support in manufacturing operations.
• Excellent written and verbal communication; client-facing ability.

Responsibilities

• Provide on-site and remote MES engineering support for pharmaceutical manufacturing operations.
• Lead design, configuration, and deployment of MES solutions in GMP environments.
• Serve as a technical SME for MES platforms, supporting production, quality, and IT stakeholders.
• Support MES lifecycle activities: requirements, config, testing, validation, deployment, and support.
• Lead or contribute to change management, impact assessments, and controlled updates.
• Support investigations, root cause analysis, and MES issue resolution.
• Lead, mentor, and grow a team of MES engineers with day-to-day leadership.
• Drive MES practice growth by standards, best practices, and technical leadership.
• Collaborate with Sales/BD to shape MES solutions and identify new opportunities.

Skills

MES experience

GMP knowledge

Problem solving

Client-facing

Communication

Education

Bachelor’s degree in Engineering/CS/IS

Tools

Emerson Syncade

Rockwell PharmaSuite

Körber PAS-X

Job description

We are seeking a Senior MES Engineer to support the expansion of our Manufacturing Execution Systems (MES) practice and provide on-site engineering support for pharmaceutical manufacturing operations in the RTP area, including.

This role will serve as a technical leader, delivering MES solutions that support manufacturing efficiency, data integrity, and regulatory compliance in GMP environments.

This is a newly created role designed to strengthen our MES capabilities, support client growth, and provide senior-level expertise for project execution and operational support.

Key Responsibilities

• Provide on-site and remote MES engineering support for pharmaceutical manufacturing operations
• 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
• Contribute to the growth of the MES practice through standardization, best practices, and technical leadership
• 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

Required 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 one or more 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

Preferred Qualifications

• Prior experience supporting large pharmaceutical manufacturing environments
• Experience with system validation, CSV, and regulated documentation practices
• Knowledge of ISA-88 / ISA-95 standards and manufacturing workflows
• Experience integrating MES with ERP, automation, or data historian systems
• Demonstrated ability to lead technical workstreams or small project teams