Your role:

  • In this position you will be responsible for Miltenyi’s internal quality management system for computerized systems and will enable the company to produce clinical products to cure cancer
  • You will design and manage compliance (“Computerized System Validation”) strategies with a strong focus but not limited to SAP ERP and will plan, implement and track validation activities
  • You will ensure adherence to GxP compliance requirements in accordance with international regulations, industry guidelines (e.g.: GAMP5) and norms and standards (e.g.: ISO13485, 21CFR11)
  • You will support of our global business with validation related strategies, methodologies, processes and activities
  • You will collaborate with global QA and GxP business areas with respect to risk management for product quality, patients safety and data integrity

 

Your profile:

  • You have successfully completed your degree in business informatics, industrial engineering or natural science
  • You have in depth Know-how in relevant GxP-regulations, in particular with aspect to computerized systems validation and ISO-regulations
  • You are a Quality-minded person with hands-on mentality, focused and with a well-organized way of working
  • You have relevant experience in medical device, medical technology, API production or drug manufacturing in pharmaceutical or related industries
  • You speak English and German fluently and experience with the DMS System Master Control completes your profile

 

What offer:

  • Flexible working hours for a family-friendly career
  • Personal and professional development in our in-house academy
  • Intercultural and cross-border collaboration
  • A modern workplace and a role you can help shape
  • Short communication lines and a collegial company culture

 

Who we are:

  • Our innovative solutions in the area of biomedical research and biomedicine make us a pioneer for the therapy of serious diseases
  • Today we are an interdisciplinary team of about 2000 employees
  • Based in Germany near Cologne and with 25 additional, international locations we are a multicultural team
  • We develop innovative cell and gene therapy solutions – together, we want to make cancer history

 

Contact us:

Miltenyi Biotec GmbH
Marcel Hirt
Teamcoordinator Talent Acquistion
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Phone: +49 2204 8306-2440
www.miltenyibiotec.com