Wake Tech offers a variety of non-degree, short classes and certificate training programs in biotechnology, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.
For those interested in earning a degree to work in the biotech industry, visit Wake Tech's Biotechnology Department.
Financial assistance available
Course details and registration information
- Demonstrate knowledge and competence in the academic and technical fields, related to bioprocess manufacturing.
- Use critical thinking to analyze and solve problems.
- Communicate effectively.
- Demonstrate positive, effective, and appropriate interpersonal skills.
- Unit 1: Pharmaceutical Quality and CGMP – quality methods, standards, and practices utilized in the biomanufacturing industry and how the federal government regulates and enforces these.
- Unit 2: Working Safely – hazards and risks within the biomanufacturing industry and how industry practices, education, and federal agencies such as OSHA work to minimize these hazards and risks.
- Unit 3: Measuring Process Parameters – process variables such as length, mass, volume, pressure, and other parameters are measured and converted back and forth between the metric and English unit systems.
- Unit 4: Chemical Processes in Biomanufacturing – introduction to common chemicals in the workplace, basic chemical safety, nature of chemicals, chemical families, chemical reactions, and mixtures / solutions.
- Unit 5: Equipment and Utilities – discussion of inputs, process steps, outputs, facility organization, process equipment (tanks, piping systems, pumps, valves, and seals), facility utilities (gases, water, steam, heating and cooling, hydraulics, electricity, and waste treatment.
- Unit 6: Controlling the Process – common unit operations, separation methods and equipment, process control parameters and methods, process control instrumentation, and manual / automatic control methods.
- Unit 7: Facilities and the Manufacturing Environment – facility design and operation considerations including biopharmaceutical facility regulatory requirements, facility monitoring and maintenance, and contamination control concerns / methods.
- Unit 8: Biomanufacturing Production – detailed discussion of biomanufacturing steps that are common to many product types and specific production steps unique to or found in a number of special product categories.
- In addition to the above-mentioned unit materials contained within the BioWork textbook, instruction and discussion about job seeking skills such as resume development, searching for jobs online, LinkedIn or other professional networking tool, and interview questions is included in this course. Students are strongly encouraged and invited to attend virtual career fairs that have as many as 30 industry partners that readily attend.
- Complying with cGMP (current Good Manufacturing Practices)
- Following an SOP (Standard Operating Procedure)
- Completing Batch Records
- Reading an SDS (Safety Data Sheet)
- An awareness of the importance of safety for the workers and product
- Using the metric system and measuring process parameters
- Understanding mechanical components of process operations (tanks, pumps, valves, etc.)
- Reading gauges
- Understanding different utility requirements (water, air, electrical, waste systems) for different parts of process operations
- Reading process diagrams and understanding feedback systems
- Determining manufacturing process similarities and differences for various product types
- Resume writing, job interview and networking skills
- Attendance 80% or above
- Tests - students must score an 80% on each unit exam to stay in the course. Students are allowed one retest of each unit exam to reach that minimum exam score of 80%
- Manufacturing Process Technician
- Bioprocess Technician
- Operation Specialist