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CSV Lead

  1. Germany, Frankfurt
Frankfurt am Main
  1. Contract
Competitive
  1. Life Sciences
36301
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CSV Lead - Frankfurt, Germany - 18 Months Contract 

We are recruiting on behalf of a leading global pharmaceutical client based in Frankfurt, Germany. Due to a large capital investment and multiple projects on site, the client is looking for a CSV Lead to join their team.

Responsibilities include:
  • Lead and manage the CSV team, ensuring timely completion of all deliverables.
  • Develop all CSV master plans and documentation.
  • Act as the lead engineer for review of PAS (existing and new), BMS, EMS, Data Historian (OSI Pi), and equipment PLC systems.
  • Identify the full scope of computer system validation and qualification efforts (GMP and non-GMP).
  • Create project-specific CSV plans for automation & IT systems, PAS, OSI-Pi, and standalone QC lab instruments.
  • Support the automation group in field execution and final report writing.
  • Lead and coordinate the APCC (Automation Project Change Control).
  • Manage and control all automation life-cycle and testing documents.
  • Generate all automation/CSV project templates.
  • Support the Design Qualification effort with CSV and automation input.
  • Attend risk assessment sessions (Complexity/Customisation, FMEA, PCL, CIL).
  • Coordinate and manage all CSV vendors, from FAT/SAT/IOQ.
  • Run and coordinate weekly CSV meetings, reporting to the CQV PM.
Key requirements include:
  • Extensive experience implementing and managing CSV scope on large-scale projects.
  • Proven experience delivering projects using a verification/leveraging approach to CSV.
  • Experience working on complex projects within the biopharmaceutical industry.

If you are local to Frankfurt ,Germany and interested in discussing this position, please submit your profile and we will be in contact at our earliest convenience.
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