Senior Automation Engineer
- BBBH771383 Dec 16, 2020 €70k - €90k
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.
- 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 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.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
353 (0) 21 2300300