Qualification / Validation Specialist (m/w/d) translates to "Qualification / Validation Specialist (male/female/diverse)" in English - Oakland, United States - BlueHorizon Solutions

BlueHorizon Solutions
BlueHorizon Solutions
Verified Company
Oakland, United States

1 week ago

Michael Johnson

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Michael Johnson

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Description


ORGENTEC Diagnostika GmbH is a global leader in the development and production of testing systems for the diagnosis of infectious and autoimmune diseases.

As part of the Sebia Group, headquartered in Lisses, France, ORGENTEC supplies medical laboratories in over 100 countries with highly specific and innovative devices and test kits.

Our company is characterized by continuous and sustainable growth in an internationally oriented and future-oriented business field.

To strengthen our Technical Operations team at our location in Mainz, we are looking for a Qualification / Validation Specialist (m/f/d) in the Engineering department.


Your responsibilities:
Planning, execution, and documentation of qualifications for production equipment, media systems, processes, and rooms in the production of diagnostic products Accompanying and conducting qualifications with the help of external service providers Planning, creation, and execution of requalifications and regular checks Creation and execution of risk analyses and initiation of resulting measures, including monitoring of implementation Development of solutions and coordination of the processing of deviations from qualification activities Creation / adaptation of standard operating procedures and training resulting from the above-mentioned activities Technical training of new employees in the qualification / validation strategy and its implementation Maintenance and summary of KPIs regarding qualification / validation topics Presentation of qualification documents in customer and regulatory audits Your qualifications: Successfully completed studies in mechatronics, mechanical engineering, electrical engineering, or a comparable field Comprehensive knowledge of GxP regulations regarding qualification of production equipment, media systems, and rooms Experience in the GxP environment
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