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Quality Engineer: Cleanroom/Equipment maintenance and qualification

For our operational site in Ghent (Belgium) we have an open position for a Quality Engineer who will be responsible for the maintenance and qualification of our cleanroom facilities and production and testing equipment.

Function

  • You are responsible for the cleanroom facility management (qualification/maintenance/ extensions) including HVAC and supportive utilities within a GMP compliant Quality Management System.
  • You are responsible for the qualification, calibration and maintenance (preventive and corrective) of production and testing equipment according to established procedures, applicable guidelines and regulations, including the supportive documentation.
  • You are the primary contact within the company for external suppliers and you are supervising the outsourced engineering, maintenance and qualification activities.
Your main responsibilities will be
  • Purchase of new equipment
    • Collect quotes and discuss technical issues with the vendors, give feed-back to the user and support the decision taking
    • Write User Requirement Specifications
    • Follow up delivery, installation, training
    • Define and write procedures for calibration, maintenance and use
    • For GMP equipment: Technical support and follow up of validation, review of protocols, perform or support the performance of IQ-OQ activities
  • Existing equipment
    • Follow up maintenance / calibration / problem solving
  • Clean rooms and Purified Water system
    • Back-up for the follow up of technical the alarms
    • Evaluation of technical alarms
    • Follow up of interventions
    • Follow up of deviations regarding technical issues
Profile
  • A professional Master degree in Engineering or equivalent technical degree (electrical, mechanical or related engineering) with a minimum of two (2) years of experience in HVAC / facility and/or equipment maintenance/qualification.
  • Experience in a GMP pharmaceutical production environment is a plus.
  • Technically skilled, hands-on, problem solver and quality minded.
  • You are used to work according to established procedures.
  • You are fluent in Dutch and have a good knowledge of English (written and spoken).
Offer
  • We offer a varied and challenging job with a permanent contract combined with an attractive salary package.
Interested in this challenging job?
  • Please send your application and CV via e-mail to Alexandrine Abbeloos (a.abbeloos@amatsigroup.com) and you will be contacted soon.