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Computer System Validation Lead

  1. Vienna
  1. Contract
Competitive
23591 / AE
  1. Commisions, Qualification and Validation
Date Posted07 Oct 2019
Do you want to be involved with an exciting long-term pharmaceutical project? Our global client is looking for Computer System Validation Lead to join their team in a picturesque Austrian location. 

The CSV Lead 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 IT part of the business for successful delivery of products to support a growing franchise.

Overview of Requirements / Job Specification:

  • Someone with great 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 (e.g. Centrifuges, Utility packages)
  • 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
  • Familiarity with Siemens PCS7 DCS and Siemens S7 PLCs and Siemens HMIs. 
  • Familiarity with IT Shop floor infrastructure
Get in touch today to find out more information or apply directly.

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