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  • DUBLIN 2
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  • Job reference number:15320688
  • Client ID:RI/JO-1712-365183_2
  • Posted on:07-FEB-2018
  • Location:WESTMEATH
  • Job type:PERMANENT

Overall Purpose: The Automation Engineer provides automation support and expertise in the build-out, equipment procurement, commissioning, validation, and tech-transfer activities associated with the start-up of the new Aerie Ireland manufacturing facility. For the on-going commercial operation of the facility, the Automation Engineer will provide technical support and lead/support continuous improvement as the automation and control system subject matter expert. The Automation Engineer will report to the Technical Services Manager.

Essential Duties, Functions and Responsibilities:

  • Works with manufacturing and quality colleagues as part of an Operations team whose shared goal is to realise the safety, quality, delivery and cost objectives of the site.
    • Prioritises safety and is diligent in the use of all appropriate safety tools and permits when working with equipment – champions safe working always.
    • Acts as Subject Matter Expert (SME) for the variety of automation systems on site. Develops an in-depth knowledge of these systems and their role in the manufacture of Aerie products.
    • Ability to program, diagnose and troubleshoot across a variety of industrial automation systems from packaging automation systems, manufacturing systems and process control solutions in a process and filling manufacturing environment.
    • As SME, develop training material to aid the training of manufacturing and maintenance colleagues in the operation and maintenance of manufacturing systems.
    • Implement software and systems changes on the automation systems according to the site’s change management processes.
    • Provides technical and automation operational support to Engineering, Manufacturing, Validation and Facilities departments.
    • Works closely with Facilities & Maintenance colleagues to provide engineering support on instrumentation issues.
    • Experience with controls networks and communications systems (Modbus, Ethernet, Profibus etc).
    • Leads the selection and management of automation support companies and in the performance of OEM (Original Equipment Manufacturer) organisations in supplying automation services to the site.
    • Supports project commissioning, qualification and validation activities.
    • Manages projects related to design, commissioning, and performance improvement of automated equipment.
    • Develop Standard Operating Procedures (SOP) for the maintenance and operation of automated Systems.
    • Maintain the validated state of automated systems. Closely aligns with Validation SMEs to ensure all Computer Systems Validation (CSV) requirements are delivered through the full computer system lifecycle.
    • Site Subject Matter Expert (SME) on the requirements regarding Electronic Records and Electronic Signatures, based on 21 CFR, Part 11.
    • Is a lead member of the site team to ensure that the site complies with the GMP requirements for data integrity across all of Aerie’s manufacturing operations.
    • Support regulatory audit\inspection as required as an SME for Aerie’s automation layers (ISA level 1 to 3).

Skills/Knowledge Required:

  • Strong technical knowledge of process control systems from level 1 to 3 on the ISA95 Hierarchy Model.
    • Strong understanding of pharmaceutical industry regulatory requirements.
  • Clear understanding of the needs of cGMP and the role of CSV as part of site compliance obligations.
    • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
Education Required :

  • B.Sc. / BE Engineering Degree in Electrical/Electronic Engineering/Automation or other Engineering discipline with the appropriate automation experience.
Experience Required:

  • 5+ years relevant experience in or supporting a pharmaceutical manufacturing environment as an automation engineer.
  • Experience of managing automation projects including external vendor management.
  • Detailed knowledge of automation system architectures.
  • Experience supporting PLC, SCADA and HMI systems in a manufacturing environment.
  • Experience supporting MES applications such as EBR, W&D, etc.
  • Packaging – serialisation experience in addition to supporting automation solutions in a high speed integrated packaging line.
  • Experience maintaining control networks and interfaces based on Ethernet and fieldbus topologies.
  • Practical database experience, scripting, or general familiarity with virtualization
    technologies and IT skills is desirable.
  • A strong knowledge of the GAMP guidelines applicable to computer system validation.
Applicants should email their cv to or call me on 01-9476227 for a confidential conversation.

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