Mannkind Corporation
Engineer III, Automation and Controls
Mannkind Corporation, Danbury, Connecticut, us, 06813
Position:Engineer III, Automation and ControlsLocation:Danbury, CTJob Id:11109# of Openings:1At MannKind, our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.Position Summary
This position is responsible for the design, development, programming, and implementation of process control systems for pharmaceutical manufacturing processes and plant facilities for full compliance with FDA regulations. Support the facility, utility, manufacturing, and packaging related control systems. Troubleshoot control and instrumentation systems and resolve discrepancies. Work with equipment vendors on purchases. Programming, installation, and configuration of automated systems. Develop and execute test strategies, prepare and execute protocols, analyze results using statistical methods, prepare technical reports, and write standard operating procedures. Participation on cross-functional teams to coordinate control related activities with external consultants, contract validation services, Process Engineering, Facilities Engineering, Manufacturing, and/or Quality. Support and perform calibrations.Responsibilities:
Design, specification, programming, simulation, and testing of control systems, utilities systems, and building automation within existing and new facilities for full compliance with FDA regulations.Provide support for all plant Automation, Process, and Robotic Systems. Analyze and troubleshoot electrical circuitry using schematics and test equipment.Supports facility, utility, manufacturing, and filling/packaging related control systems along with capital projects.Engineer and lead department assigned control system projects, vendor resources and schedules, and other necessary control system project tasks.Review documentation, methods, equipment, and procedures to improve efficiencies.Domestic and overseas travel to equipment vendor facilities for FAT execution and other project assignments.Utilize life cycle methodologies and standards (GAMP5, S88, S95, 21 CFR Part 11) for the design, development, installation, qualification, and validation of existing and future control systems and building management control systems.Other duties include troubleshooting control and instrumentation systems to resolve discrepancies, install automated systems, configure automated systems, develop test strategies, execute test strategies, prepare protocols, execute protocols, prepare technical reports, and write standard operating procedures.Develop control systems documentation, SOPs, along with system change controls, IQ, OQ, FAT/SAT/Commissioning, as required, to provide ongoing upgrades and new systems in support for cGMP Manufacturing and Utility control systems.Update and/or produce electrical drawings, control panel layouts, and other technical documentation in support of new or existing control systems.Work cross-functionally with Validation, Facilities, Calibration, Manufacturing, Process, and Engineering efforts and other cross-functional departments requiring controls related assistance and SME (Subject Matter Expert) expertise.Maintain and optimize the Calibration Data Base (Blue Mountain) as well as the Computerized Maintenance Management System (CMMS).Periodically review automation documents, preventive maintenance, and standard operating procedures to ensure compliance with GMP, environmental, and safety regulations.Develop corrective actions for automation anomalies and oversee investigations to prevent recurrence.Responsible for observing all Company, Health, Safety, and Environmental guidelines.Required Skills & Experience:
BS or Technical degree in engineering controls or a related field with 4-6 years of experience or MS/MBA with 2-4 years of experience or the equivalent combination of training and experience.In-depth knowledge of PLCs, SCADA, HMIs, Vision system, Robotics, and Visual Basic.Proven ability to program PLCs, HMIs.Effective project management skills.Working knowledge of ControlLogix, Panelviews, RSView SE, RSBatch, Asset Centre, FactoryTalk, EPAS-4, and Wonderware a plus.Understanding and knowledge of networks used in Manufacturing such as EtherNet, DeviceNet, Foundation Fieldbus, and others.Experience operating, qualifying, or developing batch processes, pure water systems, compressed air systems, HVAC systems, Filling Units, Lyophilizers, Freezers, and Refrigerators a plus.Understanding and knowledge of ISA S88 and S95.Some knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations, and industry trends.Experience working in an FDA regulated industry - knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirements.Strong technical writing, verbal communication, interpersonal, and problem-solving skills is required.Must exhibit proven ability to work independently and manage assignments cross-functionally.Working knowledge of historian data storage such as Wonderware InSQL, Factorytalk Historian, and query programs for real-time control systems a plus.Working knowledge of Microsoft Word, Excel, Visio, PowerPoint, and AutoCAD.Pay Range:
$77,600 - $110,000 per hourApply for this Position
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This position is responsible for the design, development, programming, and implementation of process control systems for pharmaceutical manufacturing processes and plant facilities for full compliance with FDA regulations. Support the facility, utility, manufacturing, and packaging related control systems. Troubleshoot control and instrumentation systems and resolve discrepancies. Work with equipment vendors on purchases. Programming, installation, and configuration of automated systems. Develop and execute test strategies, prepare and execute protocols, analyze results using statistical methods, prepare technical reports, and write standard operating procedures. Participation on cross-functional teams to coordinate control related activities with external consultants, contract validation services, Process Engineering, Facilities Engineering, Manufacturing, and/or Quality. Support and perform calibrations.Responsibilities:
Design, specification, programming, simulation, and testing of control systems, utilities systems, and building automation within existing and new facilities for full compliance with FDA regulations.Provide support for all plant Automation, Process, and Robotic Systems. Analyze and troubleshoot electrical circuitry using schematics and test equipment.Supports facility, utility, manufacturing, and filling/packaging related control systems along with capital projects.Engineer and lead department assigned control system projects, vendor resources and schedules, and other necessary control system project tasks.Review documentation, methods, equipment, and procedures to improve efficiencies.Domestic and overseas travel to equipment vendor facilities for FAT execution and other project assignments.Utilize life cycle methodologies and standards (GAMP5, S88, S95, 21 CFR Part 11) for the design, development, installation, qualification, and validation of existing and future control systems and building management control systems.Other duties include troubleshooting control and instrumentation systems to resolve discrepancies, install automated systems, configure automated systems, develop test strategies, execute test strategies, prepare protocols, execute protocols, prepare technical reports, and write standard operating procedures.Develop control systems documentation, SOPs, along with system change controls, IQ, OQ, FAT/SAT/Commissioning, as required, to provide ongoing upgrades and new systems in support for cGMP Manufacturing and Utility control systems.Update and/or produce electrical drawings, control panel layouts, and other technical documentation in support of new or existing control systems.Work cross-functionally with Validation, Facilities, Calibration, Manufacturing, Process, and Engineering efforts and other cross-functional departments requiring controls related assistance and SME (Subject Matter Expert) expertise.Maintain and optimize the Calibration Data Base (Blue Mountain) as well as the Computerized Maintenance Management System (CMMS).Periodically review automation documents, preventive maintenance, and standard operating procedures to ensure compliance with GMP, environmental, and safety regulations.Develop corrective actions for automation anomalies and oversee investigations to prevent recurrence.Responsible for observing all Company, Health, Safety, and Environmental guidelines.Required Skills & Experience:
BS or Technical degree in engineering controls or a related field with 4-6 years of experience or MS/MBA with 2-4 years of experience or the equivalent combination of training and experience.In-depth knowledge of PLCs, SCADA, HMIs, Vision system, Robotics, and Visual Basic.Proven ability to program PLCs, HMIs.Effective project management skills.Working knowledge of ControlLogix, Panelviews, RSView SE, RSBatch, Asset Centre, FactoryTalk, EPAS-4, and Wonderware a plus.Understanding and knowledge of networks used in Manufacturing such as EtherNet, DeviceNet, Foundation Fieldbus, and others.Experience operating, qualifying, or developing batch processes, pure water systems, compressed air systems, HVAC systems, Filling Units, Lyophilizers, Freezers, and Refrigerators a plus.Understanding and knowledge of ISA S88 and S95.Some knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations, and industry trends.Experience working in an FDA regulated industry - knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirements.Strong technical writing, verbal communication, interpersonal, and problem-solving skills is required.Must exhibit proven ability to work independently and manage assignments cross-functionally.Working knowledge of historian data storage such as Wonderware InSQL, Factorytalk Historian, and query programs for real-time control systems a plus.Working knowledge of Microsoft Word, Excel, Visio, PowerPoint, and AutoCAD.Pay Range:
$77,600 - $110,000 per hourApply for this Position
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