Description
Project Goal:
Lead and manage the integration of Manufacturing Execution System (MES) in a manufacturing environment, ensuring compliance with cGMP requirements.
Main Tasks:
• Provide technical guidance and support for manufacturing equipment integration with MES
• Develop and manage MES integration pack, roadmap, and deliverables
• Coordinate with site engineering leads and automation engineers
• Facilitate regular Agile planning for MES integration
• Analyze and resolve technical issues related to MES integration
• Oversee URS/FRS generation and software configuration/coding
• Manage MES software documentation practices
• Coordinate with MES platform provider, engineering contractor, and equipment vendors
Requirements:
• Strong experience with MES & Automation systems
• Thorough understanding of system cGMP requirements
• Demonstrable knowledge of computer system design and maintenance lifecycle in cGMP environments
• Experience in document lifecycle management including preparation, approval, coding, and delivery
Expected Outcomes:
• Successful integration of manufacturing equipment with MES
• Comprehensive documentation and compliance with cGMP requirements
• Effective coordination between all stakeholders in the MES integration process
Lead and manage the integration of Manufacturing Execution System (MES) in a manufacturing environment, ensuring compliance with cGMP requirements.
Main Tasks:
• Provide technical guidance and support for manufacturing equipment integration with MES
• Develop and manage MES integration pack, roadmap, and deliverables
• Coordinate with site engineering leads and automation engineers
• Facilitate regular Agile planning for MES integration
• Analyze and resolve technical issues related to MES integration
• Oversee URS/FRS generation and software configuration/coding
• Manage MES software documentation practices
• Coordinate with MES platform provider, engineering contractor, and equipment vendors
Requirements:
• Strong experience with MES & Automation systems
• Thorough understanding of system cGMP requirements
• Demonstrable knowledge of computer system design and maintenance lifecycle in cGMP environments
• Experience in document lifecycle management including preparation, approval, coding, and delivery
Expected Outcomes:
• Successful integration of manufacturing equipment with MES
• Comprehensive documentation and compliance with cGMP requirements
• Effective coordination between all stakeholders in the MES integration process