Skip to main content

CSV Engineer

  1. France
Paris
  1. Permanent
Competitive
  1. CAPEX Projects
34011

This vacancy has now expired

CSV Engineer / Lead - Paris - 12-Month Contract 

Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting for a CSV Engineer to join them on their new expansion project. Based in a charming french location, this is on a contractual basis, and will involve significantly growing the sites capacity for the manufacture of Biologics.


Responsibilities and Requirements:
  • Site Subject Matter Expert for Computerised Systems Validation.
  • Responsible for developing and managing the site strategy towards CSV.
  • Develop and manage risk-based testing strategies for computerised systems, to ensure that potential risks to product quality are appropriately managed.
  • Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
  • Support vendors to ensure adherence to, and application of GAMP
  • Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
  • Work cross-functionally to ensure site alignment with lifecycle requirements.
  • Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
  • Support development of CSV competencies within both Validation and across the business.
  • Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
  • Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment always meets regulatory requirements with a target of zero impact to routine operations.
  • Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
  • Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
  • Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
  • Application of risk and science-based tools to drive execution strategies and support issue resolution.


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

 #LI-IB1
Save as a job alert
List #1

Similar Jobs

CQV Project Coordinator

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

CQV Project Coordinator - US, North Carolina - 6-12 Months Contract    This is a fantastic opportunity for a CQV Project Coordinator  to join our major, global pharmaceutical client on their

Reference

36934

Expiry Date

01/01/0001

Mark Chaumeton Read more
QC Systems Specialist

Salary

Competitive

Location

Ireland

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

QC Systems Specialist - Ireland - 6-12 Months Contract  Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines,

Reference

36932

Expiry Date

01/01/0001

Christopher Hutchinson Read more
Senior Planning Manager

Salary

Competitive

Location

Ohio

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

Senior Planning Manager - Ohio, United States - 12 Months Contract This is a fantastic opportunity for a Senior Planning Manager to join our major, global pharmaceutical client on their latest

Reference

36828

Expiry Date

01/01/0001

Annabel Nangle Read more

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.