Responsibilities: Creation and revision of design specifications (FS, HDS, SDS) and Standard Operating Procedures (SOPs) Creation of qualification documents (IQ, OQ, PQ) Write change notes. Performing, analyzing and evaluation of Computational Fluid Dynamics (CFD) studies for pharmaceutical machines Participation in the preparation of process risk analysis Support commissioning and qualification at customer sites Support the company's strategic goals and values. Requirements: Bachelor's degree (Engineering, Science, Technical) required 3 years' experience in pharma technology required Knowledge of good documentation practices and good manufacturing practices required Experience in a regulated environment, qualification and/or validation required Strong technical expertise and analytical skills required Experience with ANSYS Discovery, ANSYS CFD Premium, or comparable computational fluid dynamics software preferred Proficient in mechanical 2D and 3D design software preferred (AutoCAD, Inventor, Solidworks) Able to read PLC programs preferred Able to read electrical schematics preferred Intermediate experience with Microsoft Office: Word /Excel /Visio /Project Available to travel up to 35% Knowledge of German language is advantageous