Qualification and Validation Engineer

Are you ready for the next step in your career? As a technical specialist in the Life Science sector, you work on technologies that improve lives. You play a key role in the development and optimization of systems for drug production, medical devices and biotechnology, for example.

Your work is crucial to the success of these projects.

Responsibilities

• As a Qualification and Validation Engineer you develop, implement, and execute URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities for small-scale equipment and related software. 
• You perform validation studies for cGMP-critical process systems to ensure compliance with cGMP, user and regulatory requirements. 
• You take a hands-on approach to validation and qualification activities. 
• You qualify systems where industry precedence exists, applying standards with case-specific interpretation in line with cGMP, cGLP, and company procedures. 
• You stay informed about evolving validation regulations and testing practices, including current US FDA and EU requirements. 
• You manage validation documentation from creation through approval and implementation. 
• You assess and provide input on changes to determine their impact on system qualification and validation documentation. 

Requirements

• 2-4 years of experience working in a healthcare manufacturing environment. 
• Experience in qualification of small-scale equipment. 
• Knowledge of cGMP requirements. 
• Understanding of relevant quality and compliance regulations.
• Experience in troubleshooting validation issues. 
• Good knowledge of Quality Management Systems. 
• Language: Dutch and English. 

At STAR, your career is our focus. We connect you with challenging projects, offer personal guidance and create opportunities with clients you are excited about.

Together we make sure you get the most out of your career.