Engineer III, Automation and Controls

$77,600 - $110,000/Yr

Mannkind Corporation - Danbury, CT

Full-time - Mid Level

Danbury, CT

Chemical Manufacturing

About the position

The Engineer III, Automation and Controls position at MannKind Corporation is a critical role responsible for the design, development, programming, and implementation of process control systems specifically tailored for pharmaceutical manufacturing processes and plant facilities. This role ensures full compliance with FDA regulations, which is paramount in the pharmaceutical industry. The engineer will support various control systems related to facility, utility, manufacturing, and packaging processes, troubleshooting any control and instrumentation systems to resolve discrepancies as they arise. In this position, the engineer will collaborate with equipment vendors for purchases and will be involved in the programming, installation, and configuration of automated systems. A significant part of the role includes developing and executing test strategies, preparing and executing protocols, analyzing results using statistical methods, and preparing technical reports. The engineer will also be responsible for writing standard operating procedures (SOPs) and participating in cross-functional teams to coordinate control-related activities with external consultants, contract validation services, Process Engineering, Facilities Engineering, Manufacturing, and Quality departments. Additionally, the engineer will support and perform calibrations as needed. The responsibilities extend to designing, specifying, programming, simulating, and testing control systems, utilities systems, and building automation within both existing and new facilities, ensuring compliance with FDA regulations. The engineer will analyze and troubleshoot electrical circuitry using schematics and test equipment, support capital projects, and lead department-assigned control system projects, managing vendor resources and schedules. The role also involves reviewing documentation, methods, equipment, and procedures to enhance efficiencies. Travel may be required, both domestically and internationally, to equipment vendor facilities for Factory Acceptance Testing (FAT) execution and other project assignments. The engineer will utilize life cycle methodologies and standards such as GAMP5, S88, S95, and 21 CFR Part 11 for the design, development, installation, qualification, and validation of control systems and building management control systems. Other duties include troubleshooting control and instrumentation systems, developing control systems documentation, and ensuring compliance with GMP, environmental, and safety regulations. The engineer will also be responsible for maintaining and optimizing the Calibration Data Base and the Computerized Maintenance Management System (CMMS).

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.
• Support 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.
• 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.
• Observe all Company, Health, Safety and Environmental guidelines.

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 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.

Nice-to-haves

• Experience with Factory Acceptance Testing (FAT) execution.
• Knowledge of advanced automation technologies and trends in the pharmaceutical industry.