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Salary A clinical-stage biopharmaceutical company developing next-generation, programmed T cell therapies based in the South West of the UK are seeking a CSV Consultant.
Scope of Work
· Delivery of IT/OT Network Qualification for New Site and OT Network Storage (S: Drive) Validation and Data Migration Qualification projects in terms of CSV
· Generating & Executing complete CSV Lifecycle documentation such as ( Creating Validation Plan, generating & Executing IQ,OQ,PQ, generating & executing Functional & Configuration specifications, support generating URS, Creating & Executing UAT, generating and executing Data Migration documents, generating Traceability matrix, generating report. Support drafting SOP).
· Working closely with IT Project Manager, SME, Validation Manager and Stake holders.
· Representing the client in key meetings with (IT/OT Network Qualification for New Site and OT Network Storage (S: Drive) Vendor to deliver the GxP projects.
Qualifications:
* Intermediate to senior (7+ years) CSV (full lifecycle) experience
* Full CSV lifecycle documentation
* IT network qualification
* SAAS enterprise
* Experience of working with software/automation validation in a project environment.
* A degree level in Engineering, or Science related area
* Hands on attitude, specifically functional testing of equipment outlined above
