Quick Overview
Job Description
Position Overview
We are seeking a system-focused MES Engineer to join our team on-site in Norwood, MA. This role focuses on the system administration, technical configuration, and integration of Manufacturing Execution Systems (MES) such as Tempo or Syncade.
The ideal candidate will bring a strong technical system perspective—focusing heavily on system-to-system integrations, data flows, and platform capabilities rather than purely operational process management. Experience supporting Drug Product manufacturing within regulated pharmaceutical or biotechnology environments is highly preferred.
Key Responsibilities
System Integration & Administration: Support the design, configuration, and maintenance of MES platforms (Tempo, Syncade, or equivalent) with an emphasis on seamless integration between MES, automation layers, and enterprise IT systems.
Technical System Management: Focus on backend system logic, data flows, interface troubleshooting, and platform performance optimization.
Programming & Data Analysis: Utilize basic programming and querying skills (SQL, Python, or C#) to analyze system performance, write data extraction scripts, and resolve technical integration issues.
Compliance & CSV Support: Ensure system changes adhere to GxP regulations, GAMP guidelines, and Computer System Validation (CSV) standards.
Cross-Functional Collaboration: Partner with automation engineers, IT integration teams, and manufacturing operations to deliver robust, compliant digital manufacturing solutions.
Required Qualifications & Technical Skills
Total Experience: 2–4 years of hands-on technical experience with MES platforms, preferably within pharmaceutical or biotechnology Drug Product manufacturing environments.
Core Systems Expertise: System-level experience with Tempo, Syncade, or equivalent enterprise MES applications.
Systems Integration: Solid knowledge of manufacturing automation systems, API/interface protocols, and system-to-system integration principles.
Programming / Scripting: Familiarity with SQL, Python, C#, or basic programming concepts for data analysis and troubleshooting.
Regulatory Understanding: Basic working knowledge of GxP regulations, GAMP guidelines, and Computer System Validation (CSV).
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