Senior Automation Engineer

Job Description

Our client are a world recoginsed company focused on developing potentially curative treatments for patients living with serious diseases.

Our client is actively seeking a Senior Automation Engineer who will build up operational technology systems across the company's Irish and UK sites. This is an exciting opportunity for a new ground breaking treatment.

Job Description

• 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

Requirements

• Bachelor's degree in Engineering from an accredited university in mechanical, chemical, or electrical disciplines with 5+ years' experience supporting or developing automated systems.
• Strong understanding of automation standards
• Experience in pharmaceutical/ biopharmaceutical drug substance manufacturing environments and processes.
• Proven programming and maintenance experience with PLCs and Software applications, ideally across several industrial platforms
• Knowledge of Building Management/Automation Systems
• Experience with supporting and maintaining automation and control system infrastructure
• Experience with various data communication protocols and architectures
• Familiarity with FDA GMPs and FDA regulations
• Familiarity with FDA regulation 21 CFR Part 11 and/or EU Annex 11

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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