Posted:4 days ago|
Platform:
Work from Office
Full Time
Job Summary
The Syncade MES Lead is responsible for overseeing the end-to-end implementation and lifecycle of the Syncade Manufacturing Execution System within a GMP-compliant environment. This role leads a cross-functional team of engineers recipe authors and validation specialists and acts as the primary technical point of contact for client stakeholders.
Responsibilities
Lead and manage MES implementation phases including design configuration validation deployment and support
Translate business requirements into Syncade system design and functional specifications
Provide governance over Syncade object modeling system integration such as DeltaV LIMS ERP and recipe lifecycle management
Conduct project planning risk management and progress tracking aligned with GxP and project goals
Serve as technical advisor for CRs GMP readiness and MES operational strategies
Create data and equipment model for implementation of MES functionalities
Author and configure MES eBRs
Development and update of SOPs
Test validate and demonstrate eBRs and provide post go-live support
7 years of MES experience with 5 years specifically in Syncade
Must have hands-on experience with deployment of MES
Strong knowledge of ISA-88 and ISA-95 standards GMP regulations and MES best practices
Strong knowledge of master data management and configuration
Strong MES integration experience with DeltaV and ERP systems
Excellent leadership communication and client engagement skills
Proven leadership in large-scale Pharma and Biotech MES deployments
Familiarity with Bioconjugate or Biologics processes
Experience using Kneat or other e-validation systems
Background in multi-site and global MES governance models
Cognizant
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