Job Description
We are recruiting for a Lead Automation Engineer. This is an initial 12 month contract based in Athlone, Ireland. PURPOSE OF JOB You 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 in Ireland. You will become the technical expert in their current control systems (including SACDA, PLCs, EMS, BMS) to enhance reliability and recommend and implement practical improvements. As such you will relish the range of accountability from hands on trouble shooting on the front-line to developing multi-year strategic plans for implementation in line with the development of their two GMP manufacturing sites and the growth of our later stage clinical pipeline. You 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. You will work with the Process Development, Manufacturing and Quality teams to design and implement automation to Gene Therapy manufacturing platforms as these emerge from Process Development and are transferred and scaled for Late Stage Clinical and commercial manufacturing processes. You will support automated equipment qualification and draft documentation for regulatory filings to advance the product portfolio. MAJOR ACTIVITIES * 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, troubleshooting 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. JOB BACKGROUND * 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. HOW TO APPLY If you're interested in this role, click 'Apply Now' to forward an updated copy of your CV