Skip to main content

CSV Engineer

  1. France
Paris
  1. Permanent
Competitive
  1. CAPEX Projects
30-04-2024
34011
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

Transversal Process Manager

Salary

Competitive

Location

Toulouse

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

France

Description

Transversal Process Manager - Pharmaceuticals - Toulouse  Our client, a global biotechnology organisation, is recruiting for a Transversal Process Manager to join their capital project in the

Reference

33960

Expiry Date

01/01/0001

Caroline O’Sullivan Read more
CQV Engineer

Salary

Competitive

Location

Copenhagen

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Denmark

Description

CQV Engineer - Process support equipment - Copenhagen -  12-Months Our client, a global CDMO in pharmaceutical manufacturing, is recruiting for a CQV Engineer to join them on their new

Reference

33455

Expiry Date

01/01/0001

Megan Luxford

Author

Megan Luxford
Read more
QC Site Operations Projects Senior Specialist

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Dublin

Description

QC Site Operations Projects Senior Specialist - Dublin - 12 month contract  Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’

Reference

33202

Expiry Date

01/01/0001

James Smithson 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.