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Junior quality assurance csv engineer | life sciences

Diegem
Capgemini Engineering
45 000 € par an
Publiée le 28 avril
Description de l'offre

Your Role

As a Junior Quality Assurance CSV Engineer, you will be part of our Life Sciences team, supporting quality assurance activities for computerized system validation projects. You will work under the guidance of senior team members to ensure systems meet quality standards and comply with regulatory requirements in the pharmaceutical industry.


Key Responsibilities

* Assisting in the execution of test protocols and documenting results according to established quality assurance procedures.
* Supporting the review of validation documentation to ensure completeness, accuracy, and compliance with regulatory standards.
* Participating in system testing activities and helping to identify and document deviations or non-conformances.
* Learning and applying GxP regulations and 21 CFR Part 11 requirements in computerized system validation.
* Contributing to quality metrics collection and reporting to track validation effectiveness and compliance.


Your Profile

* Master's degree in a related field (e.g., Biomedical Engineering, Medical sciences, Pharmaceutical sciences or similar).
* Prior experience with computerized system validation (CSV) in a regulated environment is required through past experience, internship or apprenticeship.
* Understanding of quality management systems and computerized system validation principles.
* Good analytical and problem‑solving skills with strong attention to detail.
* Ability to create clear and concise quality documentation following established templates.


What You Will Love About Working Here

* Empowering environment – Autonomy and goal setting are among the top scores with 8.4+ ratings in our monthly employee feedback Pulse.
* Inclusive leadership – Capgemini collaborates with global organizations to strengthen an equal‑opportunity framework, including promotion and pay, and to empower our leaders to develop inclusive behaviors and combat bias.
* FlexAbroad – Employees in 20+ countries can work abroad for up to 45 days in a 12‑month period.
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