Harmonics have an exciting new opportunity for an Automation Engineer based in the Mid-West for a start-up company.
The ideal candidate will be responsible for designing, developing, implementing, and maintaining industrial computerized process control and process monitoring systems (SCADA, PLC and HMIs) in a biopharmaceutical manufacturing cGMP environment.
They will become a technical expert in our current control systems (including SACDA, PLCs, EMS, BMS) to enhance reliability and recommend and implement practical improvements. They will write and/or review user requirements, functional requirement specifications, automation equipment qualification protocols, enterprise or system interfaces, process development reports, and provide technical assessments, rationales and approval for engineering and process changes to meet regulatory requirements.
• Collaborate closely with site and global stakeholders to define and deploy automation solutions including equipment, processes, and manufacturing execution systems
• Translate business, technical, and regulatory requirements into systems-level solutions during development and deployment of automated processing technologies
• Manage technical work streams with cross-functional stakeholders throughout entire project lifecycle, from concept to implementation
Lead and participate in evaluation of new technology and process automation for introduction into GMP manufacturing
• Responsible for the site PLC-based Control System, Building Management Systems, and Environmental Monitoring System, including monitoring, maintaining, trouble shooting and investigating control system hardware, wiring, and instrumentation.
• Develop, review and/or approve Preventive Maintenance Plans, Standard Operating Procedures, IQ/OQs, commissioning protocols, user requirement specifications, acceptance test plans, Functional Specifications, Design Specifications, and drawings and diagrams
• Work with site Quality and Computer System Validation personnel to ensure automation and control system GMP compliance.
• Implement and complete change controls, CAPAs, and Deviations for automated GMP systems and equipment.
• Proactively search for and implement innovative solutions to improve system performance, reliability, and compliance. • Support training efforts for new equipment installations
Bachelor’s degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with minimum 5 years’ experience, ideally 8+ years supporting or developing automated systems.
• Strong understanding of automation standards and architecture addressing batch process control, such as S88, and related automation systems, including process control systems, manufacturing execution systems, process data historians, and laboratory information management systems
• Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
• Proven programming and maintenance experience with PLCs and Software applications, ideally across a number of industrial platforms
• Knowledge of Building Management/Automation Systems
• Experience with supporting and maintaining automation and control system infrastructure, including PLCs, remote I/O panels, BMS equipment, wiring and cabling systems, as well as proprietary equipment controllers and control systems
• Experience with various data communication protocols and architectures, including ControlNet, Ethernet I/P, Modbus, BACnet and/or Profibus
• Works and communicates well in a multi-discipline team structure
• Demonstrates skills in requirements gathering, design, configuration, integration, and implementation of process control solutions for the manufacturing industry including batch software, PLC based control systems, HMI packages, building management systems, SCADA systems, and PC networking technology
• Familiarity with FDA GMPs and FDA regulations relating to biologic and drug products
• Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11