CSV Engineer
About Fortil
As an international engineering and technology consulting group, Fortil operates on an independent model and brings together over 2,500 employees worldwide. With 30 offices across 14 countries, Fortil promotes entrepreneurial freedom and the empowerment of individual potential.
Job Description – CSV Engineer
As part of the development of our activities, we are looking for a CSV Engineer to join one of our client projects.
Reporting to the Quality Manager, your main responsibilities will include:
- Defining and implementing the Computerized System Validation (CSV) strategy.
- Taking ownership of all or part of the following activities:
- Validation of automated systems, SCADA, and MES (Manufacturing Execution Systems).
- Drafting functional analyses.
- Writing test protocols, change control documents, and validation reports.
- Executing IQ, OQ, PQ qualification tests.
- Ensuring compliance with GAMP, 21 CFR Part 11, and GxP standards.
- Acting as a liaison with suppliers and/or clients.
Profile
You hold a Master’s degree (Bac+5) in a scientific field, engineering school, or pharmacy, and you have previous experience in a similar role.
You are autonomous and capable of managing some or all of the following responsibilities:
- Strong knowledge of BPF/GMP, 21 CFR Part 11, GAMP guidelines and regulations related to computerized system validation.
- Experience in drafting test cases and participating in qualification test execution.
- A genuine desire to develop your expertise and strengthen any missing technical skills.
Why Join Fortil?
At Fortil, we provide tangible support to help you grow and thrive in a stimulating work environment:
- Personalized career development and upskilling programs.
- An ecosystem that challenges your comfort zone.
- The opportunity to become a shareholder of the company.
- Involvement in social and community projects.
- A dedicated parenthood policy promoting work–life balance.
Our Commitment
Fortil is committed to equal opportunity. All our positions are open to people with disabilities, regardless of gender, origin, or sexual orientation.
- Département
- Care
- Localisations
- Agence San Diego, Agence Détroit
- Type de contrat
- CDI, CDD, Temps plein
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