Browse by job sector

CQV Lead

  1. France
Toulouse
  1. Contract
Competitive
  1. Life Sciences
34739
Apply to this job Save job
CQV Lead - Pharmaceuticals - Toulouse - 6-Months+ 

Our client, a global biotechnology organisation, is recruiting for a CQV Lead to join their capital project in the South of France. This new build facility will house a therapeutic protein production plant, and we are looking for a CQV Lead to help expand our client's biotech operations throughout Europe. As the CQV Lead you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


Reporting into the CQV Project Manager, this individual will be responsible for leading the CSV activities on a new build project:
  • CSV CQV 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.
  • 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).
  • 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).
  • Lead and manage CSV Team, ensuring at all times that all CSV schedule deliverables are met.
  • Coordinate and manage all CSV vendors, from FAT/SAT/IOQ.
  • Run and coordinate Weekly CSV Meeting, reporting back to CQV PM on deliverables.


Requirements:
  • Previous experience of working on and delivering a Verification / Leveraging approach Project for CSV work scope.
  • Minimum of 15-20 years experience implementing and managing CSV scope on Large Scale Projects.
 

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

#LI-CO1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

QC Stability Co-ordinator

Salary

Competitive

Location

Liverpool

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

England

London

Description

QC Stability Co-ordinator  - 6-month contract initially - Liverpool  Our client  is a global biopharmaceutical company manufacturing plasma-derived, and recombination therapeutic products,

Reference

34361

Expiry Date

01/01/0001

Tom Evans

Author

Tom Evans
Tom Evans

Author

Tom Evans
Read more
Read more
Project Engineer

Salary

Competitive

Location

Ohio

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

Project Engineer - Pharmaceuticals - 12-Month Contract  This is a fantastic opportunity for a Project Engineer to join our major, global pharmaceutical client on their latest new-build project

Reference

34368

Expiry Date

01/01/0001

Annabel Nangle

Author

Annabel Nangle
Annabel Nangle

Author

Annabel Nangle
Read more
Read more
Manufacturing Technician

Salary

Competitive

Location

Galway

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Ireland

West

Description

Manufacturing Technician - Pharmaceuticals - Galway - 12-Month Contract Are you a Manufacturing Technician looking for your next pharmaceutical role? Our client is a global medical technology

Reference

35146nr

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more

Insights

Day In the Life of a Commissioning Engineer Jobs

Day in the Life of a Commissioning Engineer

Read more

11/03/2024

Automation Engineer

What is an Automation Engineer and How Can I Become One?
Read more

06/01/2024

Recruiting for life sciences: all you need to know

Recruiting for life sciences: All you need to know
Read more

05/22/2024

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