Job Description
We are seeking a highly skilled MES (Manufacturing Execution System) Engineer to join our team. The ideal candidate will have strong experience in pharmaceutical manufacturing environments and a deep understanding of GxP compliance. This role involves designing, implementing, and supporting MES solutions to optimize production processes, ensure regulatory compliance, and enhance operational efficiency.
Key Responsibilities:
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-Design and Configure MES Solutions: Develop and implement MES functionalities to support batch execution, electronic batch records (EBR), and production workflows.
-System Integration: Collaborate with automation, ERP, and IT teams to integrate MES with other systems (e.g., SAP, LIMS, SCADA).
-Compliance & Validation: Ensure MES systems comply with GxP, FDA 21 CFR Part 11, and other regulatory requirements. Prepare and execute validation protocols (IQ/OQ/PQ).
-Troubleshooting & Support: Provide technical support for MES applications, resolve issues, and maintain system reliability.
-Continuous Improvement: Identify opportunities to enhance MES performance and streamline manufacturing processes.
-Documentation: Maintain accurate system documentation, SOPs, and change control records.
Additional Information
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-Education: Bachelor’s degree in Engineering, Computer Science, or related field.
-Experience:
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-Minimum 3–5 years working with MES systems (e.g., Koerber PAS-X, Rockwell Syncade, or similar).
-Must have Koerber PAS-X experience
-Knowledge of Rockwell Pharmasuite, siemens Opcenter & Emerson Syncade is an advantage
-Strong background in pharmaceutical manufacturing and GxP compliance.
-Experience with system validation and regulatory audits.
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-Technical Skills:
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-Knowledge of SQL, scripting, and system configuration.
-Familiarity with integration to ERP and automation systems.
Preferred:
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-Experience with electronic batch records (EBR) implementation.
-Understanding of ISA-95 and ISA-88 standards.
-Previous involvement in MES deployment projects in regulated environments.
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