The processes used to make small quantities of drugs in a laboratory don’t work to make the large quantities that will be sold. Engineers work with process technicians, scientists, and laboratory technicians to develop a large-scale manufacturing process for the new drug.
In some cases, engineers must design and oversee construction of a new plant. Once the plant and equipment are ready, FDA regulations require everything be tested to make sure the system will produce a drug to meet set standards. This is called validation, and requires the expertise of specialists in this field as well as engineers, technicians, and scientists.