Computerized Systems Validation consultant

Expleo offers a unique offer of integrated engineering, quality and strategic consulting services for digital transformation. In a context of unprecedented technological acceleration, we are the trusted partner of innovative companies. We help them develop a competitive advantage and improve the daily lives of millions of people.

Our workstations are accessible to people with disabilities.

Our customers are located in Puurs, Flanders.

As part of the design, modification or validation of production equipment dedicated to the pharmaceutical sector, we are looking for new employees to join Expleo Life Sciences Belgium.

If you want to invest in validation projects for computerized systems and/or automated systems in accordance with the appropriate regulations, then this role is made for you.

These are the major responsabilities:

• Participation in the development and implementation of models for the validation of the various systems;
• Involvement in the definition of user and functional needs for new systems as well as existing ones subject to validation;
• Review and validation of the documentation related to the different validation phases (IQ, OQ, PQ, URS and traceability matrix);
• Execution and monitoring of system tests;
• Creation of validation protocols and reports;
• Guarantee of project monitoring and regulatory constraints;
• Realization of Data Integrity audit.

• You have an engineering degree or an equivalent;
• You have at least 3 years of experience in the pharmaceutical or biopharmaceutical sector;
• You are familiar with the different regulations: GMP; GAMP 5, 21 CFR 1;
• You speak French and/or Dutch and have a good level of English.

• A permanent contract;
• A very large portfolio of pharmaceutical, biotechnology, medical equipment, chemical and energy customers;
• Projects going from short term (minimum 3 months) to long term (minimum 1 year);
• A salary package over 13.92 months including a company car, insurance, representation expenses, etc. Remuneration is negotiable and varies according to level of experience and skills.