Computer System Validation Lead
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
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