CSV Engineer

TN France; France; Sur place; EUR 45 000 - 70 000; Plein temps

Résumé du poste

An established industry player in the (bio)pharmaceutical sector is seeking a CSV Engineer for a 12-month contract in Hauts-de-France. This role is pivotal in enhancing the site's biologics manufacturing capacity. You will be the Subject Matter Expert for Computerised Systems Validation, responsible for developing and managing risk-based testing strategies, ensuring compliance with regulatory standards, and fostering cross-functional collaboration. If you are passionate about driving quality and safety in a dynamic environment, this opportunity is perfect for you.

Qualifications

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

Responsabilités

• Develop and manage the site strategy towards CSV.
• Ensure compliance with Environment, Health & Safety requirements.

Connaissances

Computerised Systems Validation

Risk Management

GAMP Compliance

Cross-Functional Collaboration

Formation

Bachelor's Degree in Engineering or Life Sciences

Relevant Certifications in CSV

Outils

Validation Management Software

Description du poste

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CSV Engineer / Lead - Hauts-de-France - 12-Month Contract

Our client, a global (bio)pharmaceutical manufacturing organisation, is recruiting a CSV Engineer to join them on their new expansion project. Based in a charming location in France, this is a contractual role that involves significantly increasing the site's capacity for biologics manufacturing.

Responsibilities and Requirements:

1. Site Subject Matter Expert for Computerised Systems Validation.
2. Responsible for developing and managing the site strategy towards CSV.
3. Develop and manage risk-based testing strategies for computerised systems to ensure potential risks to product quality are appropriately managed.
4. Ensure that computerised systems lifecycle requirements are embedded within projects.
5. Support vendors to ensure adherence to, and application of GAMP.
6. Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
7. Work cross-functionally to ensure site alignment with lifecycle requirements.
8. Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
9. Support development of CSV competencies within validation and across the business.
10. Ensure compliance with all applicable Environment, Health & Safety requirements by yourself and personnel operating under your remit.
11. Collectively ensure ongoing compliance of all assets at the Elstree facility within your remit, ensuring equipment always meets regulatory requirements with minimal impact on routine operations.
12. Maintain dialogue with Validation Management to deploy validation resources effectively, meeting business priorities.
13. Support implementation of validation strategies that allow work to be executed by appropriate personnel (internal and external) while maintaining standards.
14. Highlight risks to product quality, patient safety, and data integrity throughout the validation lifecycle for transparent management via a risk-based approach.
15. Apply risk and science-based tools to drive execution strategies and support issue resolution.

If this role interests you, please apply now!