CSV Engineer

San Diego, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

About Fortil

As an international engineering and technology consulting group Fortil operates on an independent model and brings together over 2500 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 Masters degree (Bac5) 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 worklife 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.

About FortilAs an international engineering and technology consulting group Fortil operates on an independent model and brings together over 2500 employees worldwide. With 30 offices across 14 countries Fortil promotes entrepreneurial freedom and the empowerment of individual potential.Job Descripti...