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Senior Validation Engineer - Automated Packaging

Abeer Ansari
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Job Reference: JO-2006-65271_1593611476


Our client is a globally innovative and market-leading medical device company focused on designing products that advance patient care while delivering clinical and economic value to health care systems worldwide. Their vision is to be the preferred partner in trauma, surgery, and sports medicine, and to achieve this, they are focused on advancing the care of patients with which ultimately saves lives.

We are currently recruiting a Senior Validation Engineer - Semi-Automated Packaging line on behalf of our client to join their team. This is a permanent position reporting to the Site Manager.

This position provides support, management, and delivery of validation activities on operations and projects at their Cork site. The role will be responsible for the design, delivery, validation, and handover of a semi-automated packaging line for the cleanroom onsite.


  • Develop Master Validation Plans

  • Develop and complete DV/IQ/OQ/PQ protocols

  • Contribute to the development of FAT/SAT protocols

  • Execute Validation Protocols, root cause deviations and generate validation reports

  • Liaise with approves and conduct approval meetings and documentation reviews

  • Develop product specifications/drawings/quality plans in conjunction with Automated Line Project Team

  • Process Risk Management / FMEA

  • Co-ordinate and implement process capability analysis on catheter processes

  • Supervision with Project Team, Quality Engineers and Associate Engineers during project activities.


  • Degree in Engineering/Science Discipline and Quality Engineering Qualification

  • 3-5 years' experience in the Medical Device Industry or similar, where utilizing automated equipment was common

  • Experience in statistical analysis / SPC / validation of automated equipment

  • Experience of people management

  • Master's degree in Engineering/Science Discipline an advantage

  • Skills in Equipment Validation, Automation, Packaging and Cleanroom are desirable

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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