MES Engineer: GxP-Savvy, ISA 88/95, ERP/LIMS Integrations

Katalyst CRO; Grand Forks (ND); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO in Grand Forks, ND seeks an MES Engineer to design, implement, and manage Manufacturing Execution Solutions within Drug Product manufacturing. You will translate processes into MES workflows, ensure GDP/GxP compliance, and integrate MES with ERP/LIMS and automation platforms.

The role involves developing modular templates based on ISA 88/95, performing validation activities, and providing day-to-day MES support to production teams, with on-call coverage for critical issues.

Qualifications

• Bachelor’s degree in engineering, CS, or related technical field.
• 2–4 years’ MES experience, preferably in pharma/biotech manufacturing.
• Familiarity with GxP, GAMP, and CSV concepts.
• Exposure to Tempo, Syncade or equivalent MES platforms.
• Basic programming concepts (SQL, Python, C#).
• Knowledge of manufacturing processes, automation, and systems integration.
• Strong problem-solving and communication skills.
• Willingness to learn and adapt quickly.
• Collaboration in cross-functional teams to deliver MES solutions.

Responsibilities

• Design and configure Tempo MES solutions including eBRs under guidance of senior engineers.
• Develop modular, scalable MES recipe templates based on ISA 88/95.
• Perform impact assessments for recipe modifications ensuring GxP compliance.
• Collaborate with cross-functional teams to gather requirements and define specs.
• Assist in recipe design and eBR authoring for MES templates following ISA 88/95.
• Troubleshoot MES issues related to configuration, recipe design, or integration.
• Integrate MES with ERP, LIMS, and automation platforms using OPC or RESTful APIs.
• Develop data visualization tools and dashboards to support operations decisions.
• Provide day-to-day MES support and participate in technical transfers for new products.

Skills

Problem-solving

Communication

Team collaboration

Learning agility

SQL

Python

C#

Education

Bachelor's degree in Engineering/CS

Tools

Tempo MES

Syncade

OPC

RESTful APIs

Job description

Katalyst CRO in Grand Forks, ND seeks an MES Engineer to design, implement, and manage Manufacturing Execution Solutions within Drug Product manufacturing. You will translate processes into MES workflows, ensure GDP/GxP compliance, and integrate MES with ERP/LIMS and automation platforms.

The role involves developing modular templates based on ISA 88/95, performing validation activities, and providing day-to-day MES support to production teams, with on-call coverage for critical issues.