Cleaning 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 Cleaning Validation Engineer, you are responsible for the  development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities.
• You develop, implement and execute validation studies for cGMP-critical process systems to demonstrate compliance with cGMP-, User- and Regulatory requirements.
• You perform validation of systems in scope for which there is industry precedence, in accordance with cGMP and cGLP procedures. 
• You ensure that the validated status of process systems in scope remains compliant  with cGMP at all times and that projects are supported in line with all required regulatory standards.
• You stay current on validation regulations and testing practices.
• You generate and manage validation documentation (protocols and reports), support execution using a paperless validation tool and assess changes for impact on validated status and documentation. 

Requirements

• Master in pharmaceutical, biotech or life sciences. 
• Experience within a GMP environment.
• Understanding of relevant quality and compliance regulations.
• Ability to troubleshoot validation-related issues.
• Experience with validation of clean steam generator systems and parts washers is an advantage.
• Good knowledge of both English and Dutch. 

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.