CSV Engineer

TN France; Toulouse; Sur place; EUR 40 000 - 80 000; Plein temps

Résumé du poste

An established industry player in the biopharmaceutical sector is seeking a CSV Engineer to support a significant expansion project in Toulouse. This role is pivotal in enhancing the site’s capacity for biologics manufacturing, ensuring compliance with stringent validation processes, and optimizing quality standards. As the Site Subject Matter Expert, you will lead the development of risk-based testing strategies and validation documentation, while fostering CSV competencies within the team. This is an exciting opportunity to make a substantial impact in a dynamic environment where your expertise will be valued and utilized to its fullest potential.

Qualifications

• Experience in Computerised Systems Validation in a pharmaceutical environment.
• Strong understanding of risk-based testing strategies and compliance.

Responsabilités

• Serve as the Site Subject Matter Expert for Computerised Systems Validation.
• Develop and manage the site strategy for CSV and ensure compliance.

Connaissances

Computerised Systems Validation (CSV)

Risk Management

Validation Documentation

Project Management

Formation

Bachelor's degree in Life Sciences or related field

Outils

Validation Management Plan (VMP)

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Description du poste

CSV Engineer – Toulouse – Contract – Life Sciences

Our client, a global (bio)pharmaceutical manufacturing organization, is recruiting for a CSV Engineer to join their team on a new expansion project. Based in Toulouse, France, this contractual role involves significantly increasing the site’s capacity for biologics manufacturing.

Responsibilities:

1. Serve as the Site Subject Matter Expert for Computerised Systems Validation (CSV).
2. Develop and manage the site strategy for CSV.
3. Create and oversee risk-based testing strategies for computerised systems to ensure product quality is maintained.
4. Integrate computerised systems lifecycle requirements into projects.
5. Manage risk-based execution to enable test data to be leveraged from commissioning to qualification phases.
6. Generate and execute validation documents such as VMP, VP, DQ, IQ, OQ, PQ, RTM.
7. Support the development of CSV competencies within Validation and across the organization.
8. Ensure compliance with all Environmental, Health & Safety requirements for yourself and your team (internal and external).
9. Implement validation strategies that optimize personnel resources while maintaining high standards.
10. Identify and communicate risks to product quality, patient safety, and data integrity throughout the validation lifecycle, applying a risk management approach.
11. Assess skills and competency development needs within the team.
12. Assist Validation Management in recruiting and onboarding staff and contractors.
13. Ensure personnel performance meets competence and behavioral standards.
14. Own the commissioning, qualification, and validation processes within your scope, ensuring consistent service delivery and process improvements.

If this role interests you, please apply now.

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