DescripciónDescriptionAble 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.
Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
*Other functions may be assigned
Requisitos RequirementsEducation:
Doctorate degree Master's degree and 3 years of directly related experience.
Bachelor's degree and 5 years of directly related experience.
Associate's degree and 10 years of directly related experience.
High school diploma / GED and 12 years of directly related experience.
Engineering (any field) or scientific background (Biology, Microbiology, Biotechnology, Chemistry, etc.)
Preferred Qualifications:
Previous experiences in regulated environment (Biotechnology, Pharmaceutical, Medical Devices, etc.). Experience in Validation with preference in Process Validation.
Skills:
In-depth knowledge of validation processes and requirements.
Interacts effectively with variety of communication and working styles.
Ability to independently determine when additional internal resources are required to solve problems.
Ability to handle multiple projects at one time.
Demonstrated Skills in the following areas: schedule development, facilitation, collaboration.
Basic project
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