MES Engineer
KeySkills
Company Name
Job Description
Job Description:
We are seeking a skilled and experienced MES Engineer with hands-on expertise in Werum PAS-X to support manufacturing operations in a regulated pharmaceutical or life sciences environment. The ideal candidate will have strong technical knowledge, validation expertise, and excellent communication skills to bridge technical teams and business stakeholders.
Key Responsibilities:
MBR Design & Development
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Design and create complex Master Batch Records (MBRs) for Weighing & Dispensing, Manufacturing, and Packaging processes.
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Analyze site-specific requirements and translate them into functional MBRs.
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Validate MBRs for deployment across manufacturing sites.
System Configuration & Administration
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Configure and customize Werum PAS-X modules such as GMBRs, PVL, PMBRs, Equipment Management, Material Flow, Weigh & Dispense, EBR, and Master Data.
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Develop State Diagrams and maintain Master Data and Equipment Management updates.
Integration & Interface Management
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Work on SAP-MES interfaces, Level 2 (L2) integrations, and report development.
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Ensure seamless data flow and interoperability between systems.
Compliance & Validation
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Ensure compliance with GxP, GAMP, and 21 CFR Part 11 standards.
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Participate in validation activities including IQ/OQ/PQ and documentation.
Project & Stakeholder Management
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Act as an Offshore Lead, managing service delivery for PAS-X.
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Collaborate with clients and stakeholders to gather requirements and deliver technical solutions.
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Provide support for Werum PAS-X installation, upgrade, development, and configuration.
Primary Skills (Must-Have):
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Strong hands-on experience with Werum PAS-X (Specification, Execution, Compliance & Performance Modules).
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Expertise in MBR creation, State Diagram design, and Master Data configuration.
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Experience in PAS-X system administration and customization.
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Knowledge of ISA-95/S88 standards and their application in MES design.
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Familiarity with SAP-MES integration and L2 automation systems.
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Understanding of pharmaceutical manufacturing processes and regulatory compliance.
Secondary Skills (Good-to-Have):
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Programming knowledge in SQL, C#, and Java.
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Experience with user management, system profile creation, and reporting tools.
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Exposure to ITIL frameworks and IT service management.
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Experience in project management, client communication, and team leadership.
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