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CSV Engineer

CSV Engineer

fortilDetroit, Michigan, .US
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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 .

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    Engineer • Detroit, Michigan, .US

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