Performance Monitoring: Monitor and analyze performance metrics related to backend processes. Identify opportunities for improvement, implement corrective actions, and track progress to achieve production targets.
Quality Assurance: Establish and maintain quality assurance measures for backend operations. Conduct regular inspections and audits to ensure compliance with specifications, standards, and customer requirements. Address any quality issues promptly and implement corrective actions.
Process Optimization: Continuously evaluate and improve backend processes to increase efficiency, reduce cycle time, minimize defects, and optimize resource utilization. Implement best practices, automation, and process enhancements.
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Performance Monitoring: Monitor and analyze performance metrics related to backend processes. Identify opportunities for improvement, implement corrective actions, and track progress to achieve production targets.
Quality Assurance: Establish and maintain quality assurance measures for backend operations. Conduct regular inspections and audits to ensure compliance with specifications, standards, and customer requirements. Address any quality issues promptly and implement corrective actions.
Process Optimization: Continuously evaluate and improve backend processes to increase efficiency, reduce cycle time, minimize defects, and optimize resource utilization. Implement best practices, automation, and process enhancements.
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Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution.
Review and verify completeness and accuracy of Device History Records (DHRs) to ensure all manufacturing, inspection, and testing activities are properly documented and meet product specifications and regulatory requirements
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Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
Ensure and monitor the applicable documents for Quality inspection are available in the point of use, this includes, but is not limited to the visual aids with physical samples.
Continuously assess and improve incoming quality inspection processes to enhance efficiency, accuracy, and reliability. Identify opportunities for automation and optimization to streamline workflows
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Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution
Leads and/or participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
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Ensure adequate steam availability and pressure stability to support production requirements, particularly for high-pressure steam and process heating applications.
Plan and execute preventive, predictive and corrective maintenance for boilers, burners, steam headers, valves, pumps, feedwater systems, deaerators, condensate systems and associated equipment.
Troubleshoot boiler and steam-system problems and lead root cause analysis (RCA) to prevent recurring failures and production interruptions.
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Oversee the mechanical integrity of key process units such as reactors, distillation columns, heat exchangers, pumps and compressors
Manage plant equipment eg. rotating & static for annual inspections, involvement in plant piping systems, material selection for corrosion resistance and managing pipe stress
Provide daily mechanical engineering support for the continuous production process, including transesterification, distillation and purification
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