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Hygiene Specialist (m/f) Vaccine Production  aseptic production Mainz Germany,  

Biontech (company)

Posted on : 10 April 2017

Project Description

  • As one of the most rapidly growing biotechnology companies in Europe, we re working on revolutionary approaches in the fight against cancer and other diseases. 
  • Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths  and ensure people all around the world have hope for the future. 
  • You too can become a pioneer!  Here, you ll achieve greatness. 
  • You will soon take the next critical step with us. 
  • With our company , you will become a worldwide forerunner in the development of a completely new type of immunotherapy against cancer using individualized tumor vaccines.

 Your duties in detail:  
  • You will soon be responsible for designing, establishing, and controlling the hygiene standards for aseptic production lines. Of course, you ensure compliance with the GMP guidelines. 
  • You develop concepts, standards, and instructions on all issues surrounding hygiene at our facilities and particularly in the production process. 
  • It goes without saying that you will keep tabs on staff members  needs for training as well as design, organi implementation of production, and carry out training sessions. Moving forward, you will oversee your colleagues' conduct in terms of adhering to hygiene standards. 
  • At the same time, you will support the schedules and validation of aseptic production processes by applying media fills. In doing so, you will be able to recognize the reasons for hygiene discrepancies and draw up suggestions for improvement. CAPAs are carried out on schedule. 
  • In close collaboration with the quality assurance department and interdisciplinary teams, you will ensure the hygiene standards are complied with.   

What you have to offer.  
  • A degree in microbiology or in engineering sciences, specializing in bioprocess engineering, pharmacy, chemistry or in a field in the food industry would be an advantage 
  • You have many years of professional experience in developing and applying hygiene standards in the food and pharmaceutical industries or a similar field. 
  • Experience in working in sterile working spaces. Knowledge of regulations and methods for microbiological monitoring. Ideally, experience in validation of antiseptics 
  • Proficiency in writing production guidelines and standard operating procedures (SOPs) in the GMP field in both German and English 
  • Competence, communication skills and the ability to assert yourself in team work and when training and leading staff members   
  • A willingness to take part in continuing training in topics new to you as well as for flexible working hours, at times in shifts, is encourage   



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