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Arcadis
Qualification and Validation Engineers

Qualification and Validation Engineers

On site

Geel, Belgium

Junior

Full Time

03-10-2025

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Skills

Quality Management

Job Specifications

Description:

Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities for small scale equipment, including the related software. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
Performs qualification of systems in scope for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP's and Sanofi Procedures.
Ensures that the qualified status of systems in scope is in compliance with cGMP at all times.
Ensures projects are supported in conjunction with all required Sanofi and cGMP regulatory standards.
Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
Responsible for the validation documentation through approval and implementation.
Provides input in review/assessment of changes to as whether they impact the qualified status and validation documentation, as appropriate.

Skills

Knowledge of CGMP requirements in a regulated environment.
Understanding of relevant quality and compliance regulations.
Capable of troubleshooting validation issues.
Good knowledge of quality management systems
Experience: 2-4 years experience working in a Healthcare manufacturing environment, with experience in qualification of small scale equipment (including the related software).

About the Company

Arcadis is a leading global partner, delivering transformative projects with businesses, cities and industries. With 36,000 people active in more than 30 countries, we bring together the best minds from around the world to deliver intelligent products and solutions that address the challenges of climate, energy security and diversification, and livable cities. We take design, engineering, architecture and consultancy to the next level, advising clients at every step of every project. From strategy and planning through to im... Know more