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Qualification Validation Engin...



GXP CONSULTING Switzerland Sàrl
Lausanne, VD
Secteur d'activités
Biotechnologie / Pharmacie
Type de poste
Temps plein
Référence de l'annonce

Qualification Validation Engineer Biotech

A propos de cette annonce








Are you passioned about the Life Sciences? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industryleaders? YES? SO DO WE!


GXP CONSULTING Switzerland is a swiss consulting company with a passioned team of Life Sciences professionals. Since 2014 we deliver outstanding industrys expertise and support to our clients in the complete range of product life cycle in the following areas:


Quality Assurance, Qualification/Validation, Regulatory Affairs, Operational Excellence,Engineering, Manufacturing and Maintenance and Project Management.


Learn more about us by visiting our webpagewww.gxp-cs.com



In order to continue tosuccessfully support our clients, currently we are looking forQualification / Validation Engineers in the biotechnology sector :


About the job:


  • Support for Biotech Process equipment (USP, DSP, Media Prep, Buffer Prep, inoculum, washing machine, autoclave, warehouse)
  • Writing of validation plans and validation summary reports
  • Review and customization of suppliers’ protocols and reports (IQ, OQ, PQ)
  • Co-ordinate qualification execution activities, including external vendors, internal departments, organizing materials, etc.
  • Manage associated qualification deviations & CAPAs, including opening, resolution (with Supplier) and closure
  • Participate in the creation and review of process Risk Assessments


About you:


  • You hold a Master’sin scientific or engineering discipline
  • You possess a minimum of5 years of experience in equipment qualification (IQ, OQ, PQ)with at least the last 3 years in the biotech sector
  • Experience in biotechnology sector mandatory
  • You possess an experience in USP and / or DSP
  • You are competent with current FDA and EU regulations and best practices
  • You are familiar with GAMP
  • You are fluent in French and English. Fluent in German is a big plus




About us:


  • Human-sized company with colleagues from diverse cultural and professional backgrounds
  • Open communication
  • Joint team spirit
  • Continuous learning and development thanks to internal trainings and workshops


At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!

If you also share the same passion and values, we will be glad to hear from you!Send us your application via email: career@gxp-cs.com