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