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Vacature Quality Engineer
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.
- 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
Amatsigroup NV (previously AmatsiQBiologicals and AmatsiSEPS), a subsidiary of Amatsigroup SAS in France, is a fast growing and dynamic company based in Ghent, Belgium offering services to third parties helping them in speeding up the development and manufacturing of their chemical and biological entities dedicated to:
- Drug product development of new drug candidates focusing on difficult to formulate drugs that are in preclinical, phase I or phase II clinical development. The company offers a full suite of drug development services encompassing preclinical development, preformulation development, formulation development, analytical development, dosage forms development, scaling-up and GMP manufacturing of chemical and biologicals drug candidates.
- Drug substance biological process and analytical method development and production, including GMP manufacturing. The principal technological expertise is production and purification of recombinant proteins derived from microbial and eukaryotic systems, for research purposes and toxicological studies as well as for clinical trials, including formulation development and stress stability studies. The company also has extensive expertise in the manufacturing of viruses and living cells for vaccine purposes and in-depth knowledge of working under pharmaceutical and GMP quality requirements.
Profiel Quality Engineer
- 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 versatile and challenging job with a permanent contract combined with an attractive salary package.
- You will join a young, dynamic and experienced team of technologists, analysts and project managers.
You can send your application and CV via email to Alexandrine Abbeloos: firstname.lastname@example.org.
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