Validation Specialist

vor 5 Stunden


Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit
About the Role

We are seeking a highly skilled Validation Specialist to join our team at agap2 - HIQ Consulting. As a Validation Specialist, you will play a crucial role in supporting our clients in the realization of their projects on site by bringing your expertise and skills.

Key Responsibilities
  • Contribute to the integration of new production equipment and utilities in a biotech/pharma environment
  • Create specifications (URS) and risk analyses (FMEA, FRA)
  • Develop and review the Validation Master Plan (VMP)
  • Participate in the creation and writing of test protocols for commissioning and qualification: FAT/SAT/IQ/OQ/PQ according to GMP requirements
  • Participate in commissioning at suppliers (FAT)
  • Participate in commissioning on customer site (SAT)
  • Perform installation and operational tests (IQ/OQ/PQ)
  • Work under the supervision of a Lead Validation
Requirements
  • Engineering degree in biotechnology, pharmaceutical sciences, process engineering or industrial pharmacist (PharmD)
  • Experience in process validation and equipment qualification in a GMP environment
  • Understanding of biotechnology production processes (USP, DSP, F&F) essential
  • Good Manufacturing Practices
  • Fluent in German and English
What We Offer
  • Join a group with strong development potential that aims to improve your employability on challenging and varied projects
  • Join a structure that has been established in Switzerland for a long time with a client portfolio that includes leaders in the sector
  • Have a sustainable job with stability and access to a real collaboration
  • Benefit from training with accredited and certified centers
  • Have a local management team to support you in the achievement of your missions and in the development of your career
  • Be part of a dynamic, committed team with real human values that we live by every day

Only applications from Swiss and EU citizens will be considered.



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