Equipment Validation & Qualification Engineer

  • permanent
  • Geneva

Due to our expansion, we are currently looking for an

 

 

Equipment Validation & Qualification Engineer

 

Missions:

The Equipment Validation & Qualification Engineer will be responsible for the Master Validation Plan: initial qualification, re-qualification of equipment and processes (including machining, special processes, up to packaging and clean room).

  • Implement and follow the process re-qualification plan
  • Ensure the qualified condition of Spineart equipment
  • Ensure of the qualified condition for the sub-contracted processes
  • Write protocols, conducts tests, monitors them, writes qualification reports
  • Participate in NC solving
  • Participate in internal/external audit plan.
  • Participate in quality project and writes technical documents for their regulatory submissions

Requirements:

  • At least 5 years’ Experience as a Qualification Engineer in medical device, pharmaceutical companies
  • Autonomous on qualification and validation activities
  • Abilities to negotiate with subcontractors (test qualification, audit, or process NC)
  • Ability to manage multiple responsibilities and tasks simultaneously
  • Writing skills in French and English
  • Solution and Customer oriented