Validation Engineer

CREGG Recruitment are currently hiring an Validation Engineer to work onsite with a leading medical device multinational client in Galway.

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.
+ Apply

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