Pharmaceutical engineering is the science and practice of designing, constructing and operating pharmaceutical manufacturing facilities that produce, label and package medicines. Pharmaceutical engineers must be knowledgeable in areas such as product development, production facilities, processes and equipment, supply chain management, quality control and regulatory compliance. Knowledge of and experience with regulatory compliance is particularly important to pharmaceutical engineers, given that the Food and Drug Administration regulates virtually every aspect of the drug development, production and sales process.
An undergraduate engineering degree is the minimum requirement to become a pharmaceutical engineer. Only a handful of schools offer a bachelor's degree in pharmaceutical engineering, so many enter the field with a chemical or industrial engineering degree. Quite a few pharmaceutical engineers, especially those planning to apply for supervisory positions, choose to go back to school to earn a master's in pharmaceutical engineering.
Product development is the first phase in the seven-to-10-year process of developing a human therapeutic. Pharmaceutical engineers with a strong background in chemistry and pharmacy might choose to specialize in product development. This type of pharmaceutical engineer works closely with biochemists, pharmacologists, materials scientists and physicians in deciding what classes of compounds to study, indications, potential formulations and methods for manufacture.
Pharmaceutical Facility Construction
Many pharmaceutical engineers are employed in the planning and construction of various types of pharmaceutical production facilities, including biotechnology manufacturing. They work closely with architects, construction management and regulatory authorities in the design, planning and construction phases of these projects. They are typically responsible for overall facility and process validation, as well as ensuring compliance with all FDA regulations and designing the facility to implement Good Manufacturing Practices.
Pharmaceutical engineers who specialize in plant plant operations or quality control often come from more traditional backgrounds, such as chemical, industrial or process engineering. Besides monitoring and fine-tuning ongoing production, plant operations engineers have to keep with all the latest developments in mixing, compounding or packaging technology so they are prepared to upgrade manufacturing processes.
Pharmaceutical engineers who specialize in QA/QC tend to be experts in regulatory compliance. These professionals work with facility management to develop comprehensive, highly documented quality control processes. Quality control experts keep their thumb on the pulse of day-to-day operations, checking deviation reports and making sure that Good Manufacturing Practices are followed throughout the production process.
- Photodisc/Photodisc/Getty Images