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Microbiology Process Validation Engineer

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Offered by:

SKAN AG

Medical
What to expectAs member of our international Microbiology Process Validation department, in this role, you will be responsible for the isolator decontamination processes (H2O2 and/or e-Beaming) development, validation, implementation and its life cycle management. You will champion best-in-class compliance with aseptic manufacturing regulations and standards. As a key player for the kledge management, you will also actively participate in consolidating and exchanging expertise with other team members and SKAN locations in USA and in Japan.  Responsibilities
  • Being SKAN product excellence ambassador at our customer site
  • Enabling customer-centric decontamination processes with the highest degree of safety and efficiency
  • Development, validation and implementation of decontamination processes
  • Process optimization and re-qualification of existing processes
  • Creation of test protocols and test reports
  • Customer-oriented troubleshooting and consultancy
  • Internal and external training of customers, presentations at company and international congresses
  • Support cross-functional technological improvement and innovations
  • Kledge exchange with other SKAN team members and locations
  • Maintenance, update and improvement of internal SOPs, documentations and workflows 
  • This function offers frequent international business travel to our SKAN customers in pharmaceutical industries (up to 50%)

 Hardskills

  • Bachelor's or master's degree in Life Science, Engineering or Technology 
  • Minimum 2 years of experiences in one of the sterilization technologies (Steam, Irradiation, ETO or H2O2) and/or Isolator decontamination (H2O2 and/or e-Beaming) 
  • Or experiences in clean room qualification within medical device and/or pharmaceutical industries  
  • od kledge in cGMP
  • Proficient presentation, writing and negotiation skills in English
  • Fluent in German and/or French is an advantage but not essential 

  Softskills

  • Professional interaction with inhouse and external customers 
  • Strong personal responsibility and motivation
  • Precise and meticulous way of working
  • High degree of adaptability and flexibility 
  • Team player
  • Desire for international business travel (up to 50%)

 We offer you

  • An open and collegial corporate culture
  • Freedom for ideas
  • Participation in sports and leisure activities
  • Promotion through further training, especially at our SKAN Academy
  • Intensive and job-oriented introduction
  • Short decision-making paths and flat hierarchies
  • Open communication policy
  • 5 weeks holidays and the possibility of further holidays

 For questions please contact Joel Streit