MES Engineer - Drug Manufacturing Systems & Compliance

Creative Solutions Services, LLC; Grand Forks (ND); On-site; USD 85,000 - 115,000; Full time

Job summary

Creative Solutions Services, LLC seeks an MES Engineer to design, implement and manage MES in our Drug Product manufacturing area. You will translate manufacturing processes into MES solutions, ensuring GDP/GxP compliance and integration with ERP/LIMS and automation platforms.

Responsibilities include configuring Tempo MES, creating reusable templates, validating changes, and developing dashboards to guide operations. Collaboration across cross-functional teams will be essential for success.

Qualifications

• Bachelor's degree in a technical field (Engineering, CS or related).
• 2–4 years of experience with MES systems, preferably in Drug Product manufacturing.
• Basic understanding of GxP, GAMP, CSV.
• Exposure to Tempo, Syncade or equivalent MES platforms.
• Familiarity with SQL, Python, or C#.
• General knowledge of manufacturing, automation and system integration principles.
• Strong problem-solving and analytical skills; ability to learn quickly.
• Excellent communication and collaboration in cross-functional teams.

Responsibilities

• Assist in design and configuration of Tempo MES solutions including eBRs.
• Develop modular, scalable MES recipe templates based on ISA 88/95 standards.
• Perform impact assessments for recipe changes ensuring GxP compliance.
• Gather user requirements and define functional specifications for MES features.
• Assist in recipe design and eBR authoring following ISA 88/95 standards.
• Perform root cause analysis for MES issues related to configuration or integration.
• Support MES integration with ERP, LIMS and automation platforms using OPC or RESTful APIs.
• Develop data visualization tools and dashboards for operations decision-making.
• Provide day-to-day MES user support and troubleshooting.
• Participate in validation activities and technical transfers for new products.

Skills

MES systems

GxP compliance

problem solving

cross-functional collaboration

SQL

Python

C#

effective communication

Education

Bachelor's degree in Engineering/CS or related technical field

Tools

Tempo MES

Syncade

OPC

RESTful APIs

Job description

Creative Solutions Services, LLC seeks an MES Engineer to design, implement and manage MES in our Drug Product manufacturing area. You will translate manufacturing processes into MES solutions, ensuring GDP/GxP compliance and integration with ERP/LIMS and automation platforms.

Responsibilities include configuring Tempo MES, creating reusable templates, validating changes, and developing dashboards to guide operations. Collaboration across cross-functional teams will be essential for success.