Automation and Controls Engineer III

6 days ago

Danbury, Connecticut, United States MannKind Full time
Job Summary

MannKind is seeking a highly skilled Automation and Controls Engineer III to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and implementing process control systems for pharmaceutical manufacturing processes and plant facilities.

Key Responsibilities
  • Design and develop 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, including analysis and troubleshooting of electrical circuitry using schematics and test equipment.
  • Support facility, utility, manufacturing, and filling/packaging related control systems along with capital projects.
  • 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.
Requirements
  • 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, Assest 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 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 hour

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