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Automation Process Engineer

Automation Process Engineer

Job Title: Automation Process Engineer
Contract Type: Permanent
Location: Galway
Salary: On Application
Start Date: ASAP
REF: 10790
Contact Name: Heather McGowan
Contact Email: sligo@icegroup.ie

Job Description

Our exclusive MedTech client in Galway city is seeking to hire an Automation Process Engineer. This role offers an excellent opportunity for an experienced Automation Process Engineer to work in a challenging and dynamic environment. You will support customers at all levels across the business in the MedTech market so experience in this sector would be a distinct advantage. 

You will be part of the site engineering team working on technical solutions for new / upgrading projects on existing systems and equipment. You will report to the Engineering Manager.

Personal Profile

  • B.Sc. in Mechanical, Industrial or other Engineering Science and demonstrated 5+ years of Validation experience.
  • Competent knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485
  • Good knowledge of ISO13485 standard
  • Excellent communicator
  • Excellent report writing, analytical and problem solving skills as well as understanding of root cause analysis methods.
  • Skilled user of engineering tools and software packages to design and automate manufacturing processes i.e.  AutoCAD, SOLIDWORKS.
  • Knowledge of Validation protocols, (FAT, SAT, CAPA, IQ/OQ/PQ, FMEA, SOP’s, Control Plans
  • Familiar with control procedures, such as the Change Notification and Deviation process, and Engineering Specifications.
  • Ability to liaise directly with clients, maintain and develop the client relationship
  • Microsoft Office Suite and Project; Statistical Process Control skills

Job Requirements and Responsibilities

  • Developing project charters, plans, schedules and implementing cost reduction plans, waste reduction, increased throughput and general operational improvement through the use of Six Sigma statistical methods.
  • Design of equipment and ensuring it is up to current regulations and design standards.
  • Reporting on new or modified equipment capabilities, qualifications (IQ/OQ/PQ), and validations.
  • Support validation assessment and validation execution for Clean, Automated and Packaging processes.
  • Assist in SAT/FAT as required.
  • Troubleshoot daily production and process problems, communicate any issues with plant management team, supervisors and operators regarding run problems, investigates root causes, recommends and implements CAs.
  • Establishing process methods which meet performance and quality requirements.