GxP MES Engineer for Drug Product Manufacturing

Katalyst CRO; Phoenix (AZ); On-site; USD 85,000 - 135,000; Full time

Job summary

Katalyst CRO is seeking an MES Engineer to design, implement, and manage Manufacturing Execution Solutions within our Drug Product manufacturing area. You will translate manufacturing processes into MES configurations, ensure GDP/GxP compliance, and integrate MES with ERP/LIMS and automation platforms.

You will assist in configuring Tempo MES, developing ISA 88/95 compliant recipe templates, and supporting data visualization and validation activities.

Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical field.
• 2-4 years of experience with MES systems, preferably in Drug Product manufacturing.
• Basic understanding of GxP regulations, GAMP guidelines, and CSV.

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 and system updates.
• Collaborate with cross-functional teams to gather user requirements and define specifications.
• Support integration of MES with ERP, LIMS, and automation platforms using OPC or RESTful APIs.
• Assist in data visualization tools and reporting dashboards for operations.
• Provide day-to-day technical support for MES users and troubleshooting.
• Participate in validation activities for MES implementations.

Skills

MES systems experience

GxP knowledge

Problem solving

Cross-functional collaboration

Communication

Education

Bachelor's degree in Engineering or CS

Tools

Tempo MES

Syncade

SQL

Python

C#

Job description

Katalyst CRO is seeking an MES Engineer to design, implement, and manage Manufacturing Execution Solutions within our Drug Product manufacturing area. You will translate manufacturing processes into MES configurations, ensure GDP/GxP compliance, and integrate MES with ERP/LIMS and automation platforms.

You will assist in configuring Tempo MES, developing ISA 88/95 compliant recipe templates, and supporting data visualization and validation activities.