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CSV Engineer

  1. France
France
  1. Contract
Competitive
  1. CAPEX Projects
30-04-2024
34014
CSV Engineer / Lead - Hauts-de-France - 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! 

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