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Comissioning Qualification and Validation Engineer
vor 1 Monat
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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Berne, Schweiz Agap2 - HIQ Consulting AG Vollzeitagap2 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...
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Comissioning Qualification and Validation Engineer
vor 3 Wochen
Berne, Schweiz Agap2 - HIQ Consulting AG Vollzeitagap2 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...
-
Qualification and Validation Engineer
vor 1 Monat
Berne, Schweiz Agap2 - HIQ Consulting AG Vollzeitagap2 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...
-
Qualification and Validation Engineer
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Berne, Schweiz Agap2 - HIQ Consulting AG Vollzeitagap2 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...
-
Qualification And Validation Engineer
vor 1 Monat
Berne, Schweiz Agap2 - HIQ Consulting AG VollzeitAs 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 environmentCreation of specifications (URS) and risk analyses (FMEA, FRA)Creation and review of the...
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