MES Engineer

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

Summary

The MES Engineer will play a critical role in supporting the design, development, implementation and management of the Manufacturing Execution Solutions (MES) within the organization's Drug Product manufacturing area. This role involves translating manufacturing processes into robust MES solutions, ensuring compliance with GxP standards, and integrating MES with other enterprise systems and automation platforms to streamline operations.

• Assist in the design and configuration of Tempo MES solutions, including electronic batch records (eBRs), under the guidance of senior engineers.
• Contribute to the development of modular, scalable, and reusable MES recipe templates based on ISA 88/95 standards.
• Perform impact assessments for recipe modifications and system updates, ensuring adherence to GxP requirements.
• Collaborate with cross-functional teams to gather user requirements and define functional specifications for MES functionalities.
• Assist in recipe design and authoring electronic batch records (eBR) to develop modular, scalable and reusable MES recipe and equipment workflow templates following ISA 88/95 standards.
• Perform root cause analysis and resolve MES issues related to system configuration, recipe design, or integration failures.
• Support efforts to integrate MES with other enterprise systems, such as ERP, LIMS, and automation platforms, using industry-standard protocols like OPC or RESTful APIs.
• Assist in the development of data visualization tools and reporting dashboards to support operational decision-making.
• Possess technical knowledge in DCS, automation, and systems integration, including the design and management of data dashboards, label management systems, and reporting tools.
• Provide day-to-day technical support for MES system users, assisting in troubleshooting and resolving recipe or system-related issues.
• Participate in technical transfer activities to ensure smooth onboarding of new products and processes into manufacturing.
• Support off-hours manufacturing operations as needed to address critical MES-related issues.
• Ensure compliance with Good Documentation Practices (GDP), GxP regulations, Data Integrity guidelines and company policies during all MES-related activities.
• Participate in validation activities to support the implementation and ongoing maintenance of MES systems.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical field.
• 2-4 years of experience with MES systems, preferably some in Drug Product manufacturing in pharmaceutical or biotechnology environments.
• Basic understanding of GxP regulations, GAMP guidelines, and Computer System Validation (CSV).
• Exposure to MES platforms such as Tempo, Syncade, or equivalent systems is preferred.
• Familiarity with basic programming concepts or languages like SQL, Python, or C#.
• General knowledge of manufacturing processes, automation systems, and systems integration principles.
• Strong problem-solving and analytical skills with a willingness to learn and adapt quickly.
• Effective communication and collaboration abilities to work in cross-functional teams.
• Commitment to maintaining compliance with regulatory and internal standards