Browse by job sector

CSV Engineer

  1. East Anglia
Toulouse
  1. Contract
Competitive
  1. CAPEX Projects
34760

This vacancy has now expired

CSV Engineer - LIMS implementation - Empower implementation - 12-Month Contract

Our client, a global biotechnology organisation, is recruiting for a CSV 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 CSV to help expand our client's biotech operations throughout Europe. As the CSV you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.


Responsibilities: 
  • Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies.
  • Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities.
  • Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports.
  • Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures.
  • Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed.
  • Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations.
  • Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices.

Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • French speaking is an ideal
  • Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology.
  • Familiarity with validation methodologies, including risk-based validation approaches.
  • Proficiency in creating and executing validation protocols and documenting validation activities.
  • Excellent analytical and problem-solving skills, with attention to detail.
  • Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
  • Ability to work independently and manage multiple projects simultaneously.


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

 #LI-CO1
Save as a job alert
List #1

Similar Jobs

Project Control Lead

Salary

Competitive

Location

Paris

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

France

Description

Project Control Lead - France, Paris - 18 Month Contract  Do you want to work at a leading global pharmaceutical manufacturer? If so, this is the assignment for you! Our global client with

Reference

37497

Expiry Date

01/01/0001

William Sweet

Author

William Sweet
William Sweet

Author

William Sweet
Read more
Read more
Project Procurement Lead

Salary

Competitive

Location

Slough

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

England

London

Description

Project Procurement Lead - UK, Slough - 12 Month Contract  Our client, a leading partner to pharmaceutical, biotech and nutrition markets, has an exciting opening for a Project Procurement Lead

Reference

37562

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
Read more
Read more
Project Technical Manager

Salary

Competitive

Location

Singapore

Salary

Competitive

Sector

CAPEX Projects

Job type

Permanent

Location

Singapore

Description

Project Technical Manager - Singapore - Permanent Contract  How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is

Reference

37557

Expiry Date

01/01/0001

Suraj Chauhan

Author

Suraj Chauhan
Suraj Chauhan

Author

Suraj Chauhan
Read more
Read more

Insights

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

Your next step as a Validation Engineer
Read more

07/20/2021

pharmaceutical factory construction

Working in an organisation from Start Up Phase

Read more

06/28/2021

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