CSV Lead

Do you want to be involved with an exciting long-term pharmaceutical project? One of our global clients is looking for a Computer System Validation Lead / Manager to join their team in a picturesque Austrian location.

The CSV Lead / Manager will play a key role in the successful delivery of this £220 million expansion and fit-out project. The project is currently in the design phase, so it is a fantastic opportunity for someone who is looking for early involvement in creation of a site and setting up the business for successful delivery of products to support a growing franchise. 

Responsabilities:

• Familiarity with Automation Qualification, GMP requirements, SDLC.
• Review and approval of Supplier provided test documentation for regulatory control as well as S88 Batch documentation deliverables.
• Support for management of Software FAT execution
• Review and guidance of Qualification documentation for packaged automation equipment 
• Development of high level automation SDLC deliverables such as Quality Assurance Plans and Quality Assurance Summary Reports.
• Regular communication with site quality representatives to plan automation qualification strategy and deliverables.
• Support for multiple automation projects
• Automation IQ/OQ/PQ support
• German Speaking
• Familiar with Siemens PCS7 DCS and Siemens S7 PLCs and Siemens HMIs
• Familiar with IT Shop floor infrastructure

Apply today if this sounds like the position for you!

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