Sr Validation Scientist

Descripción del Empleo:
Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units.
Requisitos:
Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

Assembly, Tester and Packaging processes and machines support; Basic knowledge and experience on Medical Device/Combo Product processes and regulations; Basic metrology and testing experience; Validation and Characterization experience (Protocols/URS/DS/IOQ/PQ); Basic project management skills; Basic experience in medical device assembly process; Technical Report writing skills; Basic statistical knowledge; Basic Machine troubleshooting; Basic automation knowledge (PLC, HMI, Drivers, Motors, Profibus, Device Net, Control Net); Able to work in any shift as required by the projects and activities