Validation Engineer
Cregg Recruitment are currently hiring a Validation Engineer to work in leading medical device company in Galway for more information, call Stephen Coen 0861030418 Email stephencoen@cregg.ie
About the job: Working in a large medical company you will join a team of Valdiation Engineers to work on validation protocols, validation reports, control plans for equipment
Salary & Benefits: Excellent Salary.
Working Hours: Core hours are 9:30 – 4:30 with finishing early on friday.
Key Duties and responsibilities:
- Complete validation plans, FMEAs, validation protocols, validation reports, control plans and test method validations supported with appropriate statistical tools in accordance with quality system and the requirements of ISO13485.
- Complete Process and Equipment Validation including DV, IQ, OQ, PQ protocol development, implementation and report completion.
- Develop product specifications / drawings / quality plans in conjunction with NPD and project team.
- Conduct Risk Management / FMEA / Statistical analysis.
- Complete ISO 13485 / FDA and QSR internal audits per annual schedule.
- Implement process control and ensure process capability is maintained and identify opportunities for process improvement.
- Conduct CAPA analysis to determine root cause and complete problem resolution.
Key requirements
- Level 8 qualification in Science/Engineering or Quality.
- Minimum of 3 years’ experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization
- Proven track record and performance leading validation teams within manufacturing environment
