MES Engineer

Job Title: MES Engineer

Location: Norwood, MA (Boston Area) Onsite
Duration: Long-Term Contract
Experience: 2 4 Years
Industry: Pharmaceutical / Biotechnology
Primary System: Apprentice Tempo MES

Job Summary

We are seeking an MES Engineer with experience in Manufacturing Execution Systems (MES) to support the design, development, implementation, and maintenance of Apprentice Tempo MES solutions within a pharmaceutical manufacturing environment. The ideal candidate will have experience with electronic Batch Records (eBRs), MES recipe configuration, GxP compliance, system integrations, and manufacturing operations while collaborating with cross-functional teams to ensure reliable and compliant manufacturing processes.

Must-Have Skills

• Apprentice Tempo MES (or equivalent MES platforms such as Syncade)
• Electronic Batch Records (eBR)
• GxP / GAMP / Computer System Validation (CSV)

Nice-to-Have Skills

• SQL, Python, or C#
• ISA-88 / ISA-95 Standards
• ERP, LIMS, OPC, and REST API Integrations

Key Responsibilities

• Design, configure, and support Apprentice Tempo MES solutions, including electronic Batch Records (eBRs).
• Develop modular, scalable, and reusable MES recipes and equipment workflow templates following ISA-88/ISA-95 standards.
• Perform impact assessments for MES recipe modifications and system updates while ensuring GxP compliance.
• Gather business and manufacturing requirements and translate them into functional MES solutions.
• Troubleshoot MES configuration, recipe, and integration issues through root cause analysis.
• Support integration of MES with ERP, LIMS, and automation systems using OPC and REST APIs.
• Develop and maintain dashboards, reporting tools, and manufacturing data visualization solutions.
• Provide day-to-day technical support for manufacturing users and resolve MES-related production issues.
• Participate in technology transfer activities for new products and manufacturing processes.
• Support validation, testing, and documentation activities in compliance with GxP, GDP, Data Integrity, and CSV requirements.
• Provide off-hours production support when required.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field.
• 2 4 years of experience with MES systems in pharmaceutical or biotechnology manufacturing.
• Hands-on experience with Apprentice Tempo MES, Syncade, or similar MES platforms.
• Understanding of electronic Batch Records (eBR) and manufacturing execution processes.
• Knowledge of GxP regulations, GAMP guidelines, Data Integrity, and Computer System Validation (CSV).
• Basic programming knowledge in SQL, Python, or C#.
• Familiarity with manufacturing automation systems, ERP, LIMS, and system integration concepts.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent communication and collaboration skills.

Preferred Qualifications

• Experience supporting Drug Product manufacturing operations.
• Knowledge of DCS, PLC, SCADA, and automation systems.
• Experience with reporting tools, label management systems, and manufacturing dashboards.
• Understanding of pharmaceutical manufacturing processes and regulatory requirements.
• Exposure to Agile or project-based implementation methodologies.

Top 3 Responsibilities

1. Configure, develop, and support Apprentice Tempo MES solutions, including electronic Batch Records (eBRs).
2. Integrate MES with ERP, LIMS, and automation systems while ensuring GxP and CSV compliance.
3. Provide technical support, troubleshoot manufacturing issues, and optimize MES performance in a regulated pharmaceutical environment.