Senior Validation Engineer - Cork, Ireland
Posted on Jul 13, 2020 by eTeam Inc.
Job Title: Senior Validation Engineer
Duration: 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.
- Equipment Validation,
- Clean Room
- 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
- 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