Browse by job sector

CSV Lead

  1. Germany, Frankfurt
Frankfurt am Main
  1. Contract
Competitive
  1. Life Sciences
36301

This vacancy has now expired

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.
 #LI-AB3
Save as a job alert
List #1

Similar Jobs

ASL Scientific Director

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

Ireland

Dublin

Description

ASL Scientific Director - Ireland, Dublin - 12 Month Contract  One of the top 10 best companies to work in Ireland is looking for an ASL Scientific Director for their large-scale new facility in

Reference

38287

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Construction Turnover Lead

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

North America

East Coast

Description

Construction Turnover Lead - Raleigh, North Carolina - 3 Month Initial Contract Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries

Reference

38284

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
Clean Room SME

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

North America

East Coast

Description

Clean Room SME - North Carolina, Raleigh -  3 Month Initial Contract  Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries

Reference

38283

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more

Insights

QCS Staffing Validation Engineer Jobs: In-Demand Skills and Career Paths

Validation Engineer Jobs: In-Demand Skills and Career Paths
Read more

05/27/2025

QCS Staffing A Guide to Pharmacovigilance Careers

A Complete Guide to Pharmacovigilance Careers
Read more

05/15/2025

Living and working in Ireland
Read more

03/12/2025

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV