CSV Lead

CSV Lead - Netherlands, Eindhoven - 12 Months Contract 

Do you want to be involved with exciting pharmaceutical projects?

When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a CSV Lead.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:

• 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 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.

Desirable Experience:

• Requires 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 this role is of interest to you, please apply now!

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