What are the responsibilities and job description for the Senior MES Engineer position at Orise?
Job Description
Position Summary
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.
Key Responsibilities
Required Qualifications
Position Summary
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.
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
- 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