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Principal Engineer, Automation

4 months ago

Bridgeport, United States Recruits Lab (We're hiring) Full time

Position Summary:

This role involves leading the design, development, programming, and implementation of new systems and controls for future pharmaceutical manufacturing processes and plant automation systems, ensuring full compliance with FDA regulations. Reporting directly to the site lead for systems and controls, this position supports facility, utility, manufacturing, and packaging-related control systems. Responsibilities include training, designing, and troubleshooting control and instrumentation systems to resolve discrepancies, managing current and future equipment purchases, vetting preferred vendors, and insourcing contracted labor.

The role is hands-on, involving programming, installation, and configuration of systems, creating design experiments for testing, executing test strategies, preparing and executing protocols, analyzing results using statistical methods, and preparing technical reports and standard operating procedures. The position also manages project schedules, coordinates control-related activities across various departments, supports and performs calibrations, and leads department control system projects.

Responsibilities:

  • Proficient in Allen-Bradley PLC programming, FactoryTalk SE/ME (HMI), Servo drives, ELAU, B&R PLC programming, and Zenon SCADA.
  • Solid understanding of industrial computers, networking, and communication protocols, with the ability to troubleshoot equipment and perform complex system tests.
  • Desired experience with Rockwell Automation RsLogix5000, Siemens S7 TIA portal, ELAU PLC software, Wonderware InTouch, Wonderware Industrial Application Server, motion control, Cognex and Keyence vision systems, fieldbus communications (Ethernet/IP, Profibus, DeviceNet, ControlNet), robotics, Kepware software, and Safety PLCs.
  • Design, specification, programming, simulation, and testing of control systems, utility systems, and building automation for FDA compliance.
  • Create proactive plans to minimize downtime of plant automation, process, and robotic systems.
  • Analyze, troubleshoot, and create electrical circuitry using schematics and Autodesk.
  • Lead and support facility, utility, manufacturing, and packaging-related control systems and capital projects.
  • Support cross-functional teams and perform domestic and overseas travel for project assignments.
  • Utilize life cycle methodologies and standards (GAMP5, S88, S95, 21 CFR Part 11) for control systems and building management.
  • Evaluate and upgrade legacy equipment to meet obsolescence initiatives.
  • Develop and update control systems documentation, SOPs, system change controls, IQ, OQ, FAT/SAT/Commissioning, and other technical documentation.

Required Skills & Experience:

  • BS or Technical degree in engineering controls or related field with 10-15 years of experience, or MS/MBA with 7-10 years of experience, or equivalent combination of training and experience.
  • In-depth knowledge of PLCs, SCADA, HMI, Vision systems, Robotics, and Visual Basic.
  • Proven PLC and HMI programming ability.
  • Effective project management skills (PMP preferred).
  • Subject matter expert in Allen Bradley and Siemens controllers, with graphical HMI design ability as a plus.
  • Mastery knowledge of industrial networks (EtherNet, DeviceNet, Foundation Fieldbus).
  • 5+ years of experience with batch processes, pure water systems, compressed air systems, HVAC systems, and filling units.
  • Understanding and knowledge of ISA S88 and S95.
  • Experience in regulated industries (Medical/Aerospace/Automotive), knowledge of cGMPs, GAMP, and 21 CFR part 11 validation.
  • Mastery-level technical writing, verbal communication, interpersonal, and problem-solving skills.
  • Proven ability to work independently, lead teams, and manage cross-functional assignments.
  • Mastery level knowledge of historian data storage (Wonderware InSQL, Factorytalk Historian), real-time control systems, and query programs.
  • Onsite work required with limited remote work capabilities; must be hands-on and work closely with mechanics, production engineers, and interns.
  • Proficiency in Microsoft Word, Excel, Visio, PowerPoint, AutoCAD. Solidworks and G-code experience are a plus.