Senior CSV Engineer (m/f/d)

The Senior CSV Engineer will operate with the Orise project teams in performing GxP Computerised Systems CSV, Consulting and Project Management activities.

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• Management of client CSV activities and relationships
  
• Working as part of client project teams to define CSV strategy for projects
  
• Delivering front end consultancy services as part of ongoing business development
  
• Preparation/testing of validation protocols, and all associated documentation for GxP Computerised Systems.
  
• Support the operation of systems by executing Periodic Reviews, Change Controls and Audit Trail Reviews.
  
• Provide assistance with the generation of CSV related documentation.
  
• Act as Process Champion taking ownership of internal processes to continually develop and improve them as part of the company continual improvement process; be the ‘go-to’ person for the designated process (s)
  
• Develop and maintain designated client site expertise to enhance the relationship and efficiency between Orise and respective client.
  
• Working as part of Orise and client teams in the development of GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets e.g. Lab, Automation, Business and Equipment systems.
  
• Review/Approval of all GxP Computerised Systems Validation Documentation.
  
• Administration of GAMP lifecycle across concurrent projects.
  

Any other duties which may be assigned from time to time.

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• A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or 8 years’ relevant experience). xcfaprz
  
• A minimum of 6 years CSV experience in the Life Sciences sector
  
• Subject matter Expert (SME) in relation to the regulations (FDA, EMA, other) and guidelines (GAMP,PICs, other) that underpin Computerised Systems Validation (CSV) within the life science industry
  
• Project management qualification preferred but must have a history of managing multiple concurrent projects
  
• Detailed knowledge of regulatory guidance documents and standards
  

Experience in the validation of laboratory equipment is a plus.