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CSV Lead

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
11-06-2021
26514

This vacancy has now expired

CSV Lead - Global Biopharmaceutical Client - USA

Our client is making a significant capital investment for a new biologics facility in the USA and requires a CSV Lead to work on the multi-billion-dollar project.

 
The Role:
  • CSV Lead for generation of all CSV Master Plans and Documents. Lead engineer for review of PAS, both existing and new.  BMS, EMS, Data Historian, OSI Pi and Equipment PLC systems.
  • Manage CSV Group for Project from Design through to PPQ Stage.
  • During BOD clearly Identify and Develop the “Basis of Design Document” with the Automation and IT Team. Fully identify full scope of all Computer System Validation Qualification effort to be implemented for the Project, both GMP and Non-GMP Systems. 
  • With “BOD Document for Automation and IT systems” then develop and establish the AIS Validation Master Plan and Identify the subsequent Child Validation Plans for the subsequent AIS 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).
  • Have overall management and control of all automation lifecycle and testing documents.
  • Also responsible for generating all Automation/CSV Project Templates.
  • Support Design Qualification effort in relation to all CSV and Automation input for DQ and DQ Reporting.
  • Attend Risk Assessments sessions, representing Automation/CSV, including; Complexity/Customization, FMEA, Product Contact List (PCL) and Critical Instrument List (CIL).
  • Coordinate and manage all CSV vendors, from FAT/SAT/IOQ.
  • Run and coordinate Weekly CSV Meeting, reporting back to CQV PM on deliverables.
 
If this opportunity interests you, please apply.



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