Description
Apply chemical engineering, biology, and biochemistry to design, develop, scale up, and optimize bioprocesses and products such as biopharmaceuticals, enzymes, biofuels, and industrial biochemicals, integrating bioreactor design, fermentation, downstream purification, process modeling, and quality systems to deliver safe, efficient, and compliant manufacturing.
- • Evaluate the safety, efficiency, and effectiveness of bioprocess equipment and utilities.
- • Advise manufacturing staff on fermentation, filtration, and other bioproduction operations.
- • Research new biocatalysts, cell lines, media, and separation materials for improved performance.
- • Develop models or computer simulations of bioreactors and kinetics to predict process behavior.
- • Conduct research with life scientists and chemists on engineering aspects of microbial and mammalian cell systems.
- • Design or adapt process control hardware and software for monitoring, automation, and data acquisition.
- • Analyze new or revised bioprocess procedures to forecast yield, quality, cost, and risk.
- • Train operators and technicians on proper use of bioprocess equipment and SOPs.
- • Write protocols, batch records, maintenance procedures, and equipment standards.
- • Collaborate with quality assurance to prepare specifications, SOPs, user manuals, and qualification or validation reports.
- • Communicate with regulatory authorities regarding GMP, biosafety, and environmental compliance.
- • Communicate with suppliers on design and specifications for bioreactors, sensors, single-use systems, and chromatography media.
- • Confer with R&D and manufacturing teams to ensure design-for-manufacture and process scalability.
- • Consult with chemists or biologists to develop or evaluate novel biocatalytic or metabolic engineering technologies.
- • Design and direct bench, pilot, and scale-up experiments to optimize yield and reduce costs.
- • Develop bioremediation or waste treatment processes to reduce pollution and treat effluents.
- • Create methodologies and documentation for technology transfer from lab to commercial-scale manufacturing.
- • Develop statistical models and simulations and use DOE to characterize and control processes.
- • Lead studies to improve process sequences, cycle times, and operating parameters.
- • Maintain databases or electronic lab notebooks of experiment parameters and results.
- • Manage engineering teams and projects, including schedules, budgets, inventory, and vendor contracts.
- • Prepare project plans for facility and equipment upgrades, including timelines and capital estimates.
- • Prepare technical reports, data summaries, regulatory submissions, and patent applications.
- • Review existing manufacturing processes to identify opportunities for yield improvement and reduced variation.
- • Recommend process formulas, media compositions, instrumentation, and equipment specifications based on pilot results.
- • Read current scientific and trade literature to stay abreast of bioprocess technologies and regulations.
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Advanced Manufacturing
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O*NET occupational data (work activities, skills, knowledge).
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This site includes information from O*NET by the U.S. Department of Labor, Employment and Training Administration (USDOL/ETA), used under the CC BY 4.0 license. Career Clutch has modified some of this information for student readability. USDOL/ETA has not approved, endorsed, or tested these modifications. O*NET® is a trademark of USDOL/ETA.
Last reviewed: Jan 2026
