CSV Engineer

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 site's 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 of 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!