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At 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 leading the design, development, programming and implementation of new systems and controls for future pharmaceutical manufacturing processes and plant automation systems for full compliance with FDA regulations, reporting directly to the site lead for systems and controls. Support the facility, utility, manufacturing and packaging related control systems. Train, Design, and Troubleshoot controls and instrumentation systems to resolve discrepancies. Lead current and future equipment purchases, while vetting preferred vendors and insourcing contracted labor. Leads through hands on methodology to programming, installation, and configuration of systems. Create design of experiments for testing and execute test strategies, prepare and execute protocols, analyze results using statistical methods, prepare technical reports and write standard operating procedures. Manage project schedules through integrated product teams to coordinate control related activities, validation, Process Engineering, Facilities Engineering, Manufacturing, and/or Quality. Support and perform calibrations. This position is hands-on management leading by doing, training, and supporting teams throughout the organization.
Responsibilities:
- Direct experience with Allen-Bradley Programmable Logic Controllers (PLC) programming, FactoryTalk SE/ME (HMI), Servo drives, ELAU, B&R PLC programming, Zenon SCADA and supporting software is required.
- Solid understanding of computers, networking and communication protocols used with industrial controllers, along with the ability to troubleshoot equipment problems and perform complex system tests.
- Knowledge of Rockwell Automation RsLogix5000, Siemens S7 TIA portal, ELAU PLC software, Wonderware InTouch, and Wonderware Industrial Application Server is highly desired.
- Experience with motion control, Cognex and Keyence vision systems, fieldbus communications (Ethernet/IP, Profibus, DeviceNet, ControlNet etc.), robotics, Kepware software and Safety PLCs is desired.
- 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.
- Create proactive plans to ensure all plant Automation, Process, and Robotic Systems have minimized downtime. Analyze, troubleshoot, and create electrical circuitry using schematics and autodesk.
- Leads and Supports facility, utility, manufacturing and filling/packaging related control systems along with capital projects.
- Execute with minimal guidance from Director of Systems and Controls Engineer, and lead department control system projects, schedules, and other necessary control system project tasks.
- Supports facility, utility, future manufacturing and filling/packaging related control systems along with capital projects.
- Review documentation, methods, equipment, and procedures to improve efficiencies.
- Domestic and overseas travel to equipment vendor facilities for FAT execution and other project assignments (<5%)
- 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.
- Evaluate and select upgrades for legacy equipment to ensure proper part obsolescence initiatives are met.
- Other duties include, but not limited to, 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.
- Maintains and optimizes 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.
- Execute with minimal guidance from Director of Systems and Controls Engineer, and lead department control system projects, schedules, and other necessary control system project tasks.
- Supports facility, utility, future manufacturing and filling/packaging related control systems along with capital projects.
- Review documentation, methods, equipment, and procedures to improve efficiencies.
- Domestic and overseas travel to equipment vendor facilities for FAT execution and other project assignments (<5%)
- 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.
- Evaluate and select upgrades for legacy equipment to ensure proper part obsolescence initiatives are met.
- Other duties include, but not limited to, 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.
Required Skills & Experience:
- BS or Technical degree in engineering controls or a related field with 10-15 years of experience or MS/MBA with 7-10 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. PMP preferred.
- Subject matter expert knowledge of Allen Bradley and Siemens controllers. Graphical layout and design ability for HMI's a plus.
- Mastery knowledge of networks used in Manufacturing such as EtherNet, DeviceNet, Foundation Fieldbus, and others.
- 5+ years experience operating, qualifying or developing batch processes, pure water systems, compressed air systems, HVAC systems, and Filling Units. (Lyophilizers, Freezers and Refrigerators a plus)
- Understanding and knowledge of ISA S88 and S95.
- Subject Matter Expert of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations and industry trends.
- Sr. Level experience working in a regulated industry (Medical/Aerospace/Automotive), Knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirement a plus.
- Mastery level in technical writing, verbal communication, interpersonal and problem-solving skills is required.
- Proven ability to work independently, lead a team of peers and manage assignments cross-functionally.
- Mastery level knowledge of historian data storage such as Wonderware InSQL, Factorytalk Historian, and query programs for real-time control systems a plus.
- Onsite work required, limited ability to be virtual/remote. Must be able to be "get dirty" and work hand and hand with mechanics, production engineers and interns. Position is not desk bound.
- Mastery level knowledge of Microsoft Word, Excel, Visio, PowerPoint, and AutoCAD. Solidworks and G-code experience a plus.
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