Csv Lead
Vor 2 Tagen
CSV Lead - Contract - Biotechnology - Switzerland
We have an exciting new requirement for a CSV Lead in support of a major CapEx investment project in Europe Our client are a global biotechnology company with plans of expansion across Europe, and this is an excellent time to get involved.
Supportiung the installation and commissioning of Delta V and bespoke control systems on a large drug substance facility, you will be responsible for vendor and stakeholder oversight, documentation management and the oversight of commissioning activities.
**CSV Lead Responsibilities**:
Generate all CSV Master Plans and Documents.
Be the lead engineer for review of PAS, both existing and new (BMS, EMS, Data Historian, OSI Pi and Equipment PLC systems).
Liaise with CQV PM in relation to CSV portion of Project Schedule.
Manage CSV Group for Project from Design through to PPQ Stage.
Identify full scope of all Computer System Validation Qualification effort to be implemented for the Project, both GMP and Non-GMP Systems.
Plan Computer Systems Validation Master Project Plan for the Automation & IT computer Systems, PLAN- Validation Project Plan (VPP) for PAS and OEM Automation Computer Systems, PLAN- Validation Project Plan for OSI-Pi Site Historian and PLAN-Computerized Systems Validation Project PLAN for Standalone QC laboratory instruments.
Support Automation Group in field execution and Final Report writing. Lead and coordinate the APCC (Automation Project Change Control).
Support Design Qualification effort in relation to all CSV and Automation input for DQ and DQ Reporting.
**About you**:
Previous experience of working on and delivering a Verification / Leveraging approach Project for CSV work scope.
Significant experience implementing and managing CSV scope on Large Scale Projects.
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