Pharmaceutical Engineering - Professional Licensure/Certification

Professional Licensure/Certification

In most jurisdictions, engineering licensure (e.g. Licensed "Professional Engineer" or P.E.) is not discipline-specific, so any licensed engineer with competency in pharmaceutical engineering may qualify as licensed. However, in the U.S., most pharmaceutical engineers fall under the "industrial exemption," which does not require a (P.E.) license for those engineers whose work is completely internal and for a private employer. There are ongoing debates about whether to narrow or eliminate this exemption from engineering licensure, and the Executive Director of the National Society of Professional Engineers (NSPE) recently advocated requiring licensure for engineers in the pharmaceutical industry (among a few others).

Most U.S. jurisdictions require two examinations as part of their licensing criteria, the second of which allows electing a particular discipline of emphasis (while not affecting the license itself, as noted above), so pharmaceutical engineers are likely to select the testing option of either chemical engineering or biomedical engineering (which are generally considered the closest available options).

There is also a private (non-governmental) certification offered by the professional organization International Society for Pharmaceutical Engineering (ISPE), known as Certified Pharmaceutical Industry Professional (CPIP). This tends to focus more on (later-stage) manufacturing and commercialization issues, etc., rather than early-stage things like drug design, discovery assays, and preclinical development.