CSV Engineer

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 position is on a contractual basis and will involve significantly growing the site's capacity for the manufacture of Biologics.

Responsibilities:

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 that potential risks to product quality are appropriately managed.
4. Ensure that computerised systems lifecycle requirements are embedded within computerised systems projects.
5. Manage risk-based execution to ensure test data may be leveraged from commissioning testing into qualification.
6. Generate and execute VMP, VP, DQ, IQ, OQ, PQ, RTM.
7. Support development of CSV competencies within both Validation and across the business.
8. Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
9. Support the implementation of validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
10. 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.
11. Identify skills and competency development needs within the team.
12. Support Validation Management in the identification, recruitment, and onboarding of resources (staff and contract) into the organisation.
13. Ensure that the performance of the personnel (internal and external) operating under your remit meets the standards (competence and behavioural).
14. Ownership of commissioning, qualification, and validation implementation within your remit and, in conjunction with your peer group, across the validation team to ensure consistent service delivery and systemic application of process improvements.

If this role is of interest, please apply now.