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.
- 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
- 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).
- 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 (email@example.com) and you will be contacted soon.