CSV Engineer - US

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 (US) 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 .