Qualification and Validation Engineer

vor 3 Wochen

Bern, Schweiz Agap2 - HIQ Consulting AG Vollzeit

agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills.

You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio.

Qualification and Validation Engineer (Pharma/Biotech)

As a CQV Engineer you would primarily responsible for the preparation and the execution of the Commissioning & Qualification activities, including the following:

 

  • Contribute to the integration of new production equipment and utilities in a biotech/pharma environment
  • Creation of specifications (URS) and risk analyses (FMEA, FRA)
  • Creation and review of 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

 

Your profile:

  • 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

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