MES Engineer – Drug Product Manufacturing & Compliance

Katalyst CRO; Tallahassee (FL); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO seeks an MES Engineer to design, implement and manage Manufacturing Execution Solutions within Drug Product operations, translating processes into robust MES configurations while ensuring GxP & GDP compliance.

You will work with Tempo and Syncade, develop reusable recipe templates, validate changes, and collaborate with ERP, LIMS and automation teams to optimize data flow.

Qualifications

• 2–4 years of MES experience, preferably in pharma/drug product manufacturing.
• Bachelor's degree in Engineering, CS or related technical field.
• Familiarity with GDP, GxP, CSV and regulatory concepts.
• Exposure to Tempo, Syncade or equivalent MES platforms.
• Basic programming concepts in SQL, Python, or C#.
• Strong problem-solving and cross-functional collaboration abilities.

Responsibilities

• Design and configure Tempo MES solutions including electronic batch records (eBRs).
• Develop modular MES templates based on ISA 88/95 standards.
• Perform impact assessments for recipe changes and system updates with GDP/GxP compliance.
• Collaborate with cross-functional teams to define functional specifications.
• Assist in recipe design and writing eBRs for MES templates.
• Resolve MES issues related to configuration, recipe design, or integration failures.
• Support MES integration with ERP, LIMS, and automation using OPC/REST APIs.
• Develop data visualization tools and dashboards for operations.
• Provide day-to-day MES user support and assist in technical transfers.
• Participate in validation activities for MES implementations.

Skills

MES experience

GxP knowledge

SQL

Python

C#

ISA 88/95

Regulatory compliance

Cross-functional collaboration

Data integration

Problem-solving

Education

Bachelor's degree in Engineering or CS

Tools

Tempo MES

Syncade

ERP systems

LIMS integrations

Job description

Katalyst CRO seeks an MES Engineer to design, implement and manage Manufacturing Execution Solutions within Drug Product operations, translating processes into robust MES configurations while ensuring GxP & GDP compliance.

You will work with Tempo and Syncade, develop reusable recipe templates, validate changes, and collaborate with ERP, LIMS and automation teams to optimize data flow.