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Senior Validation Engineer - Cork, Ireland

Posted on Jul 13, 2020 by eTeam Inc.

Cork, Ireland
Immediate Start
Annual Salary

Job Title: Senior Validation Engineer
12 +- Long Term

Job Purpose and primary objectives:

  • Design, delivery, validation and handover of a semi-automated packaging line for Cleanroom at project - Cork plant.

Key Skills/Knowledge:

  • Equipment Validation,
  • Automation
  • Packaging.
  • Clean Room

Key responsibilities

  • 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.

Experience required:

  • Degree in Engineering/Science Discipline and Quality Engineering Qualification
  • Experience in statistical analysis/SPC/validation of automated equipment
  • Good experience in Medical Device Industry utilizing automated equipment
  • Experience of people management

Master's degree in Engineering/Science Discipline an advantage

Reference: 910182756

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