CSV Engineer

TN France; Paris; Sur place; EUR 60 000 - 100 000; Plein temps

Résumé du poste

An established industry player is seeking a CSV Engineer to lead their expansion project in Paris. This role is pivotal in ensuring the quality and compliance of computerised systems within a growing biopharmaceutical environment. You will be responsible for developing risk-based testing strategies and managing the site’s validation efforts. This exciting opportunity offers a chance to work in a charming French location, contributing to the manufacture of biologics while ensuring adherence to regulatory standards. If you are passionate about quality assurance and thrive in a collaborative setting, this position is perfect for you.

Qualifications

• Experience in Computerised Systems Validation as a Subject Matter Expert.
• Proven track record in developing risk-based testing strategies.

Responsabilités

• Develop and manage strategy for Computerised Systems Validation.
• Ensure compliance with Environment, Health & Safety requirements.
• Support development of CSV competencies across the business.

Connaissances

Computerised Systems Validation

Risk Management

GAMP Compliance

Cross-Functional Collaboration

Formation

Bachelor's Degree in Engineering or Life Sciences

Relevant Certifications in CSV

Description du poste

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CSV Engineer / Lead- Paris - 12-Month Contract

Our client, aglobal (bio)pharmaceutical manufacturing organisation, is recruiting for aCSVEngineerto 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 ofBiologics.


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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