Wake Tech offers short, non-degree classes and certificate programs in biotechnology. Students get hands-on experience in biomanufacturing and biopharmaceutical operations in a simulated industrial setting that follows current Good Manufacturing Practices (cGMP). This training prepares students for jobs in the biotech industry by focusing on real-world skills and industry standards.
Interested in earning a degree to work in the biotech industry? Visit Wake Tech's Biotechnologies Division.
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 them.
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 tools and interview questions is included in this course. Students are strongly encouraged and invited to attend virtual career fairs that as many as 30 industry partners attend.
150
Yes
Partnership for Biotechnology Workforce Training - Process Technician Examination
https://www.scantron.com/wp-content/uploads/2019/07/NCBC-Candidate-Guid…
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
Bioprocess Practices, BPM-110, and Industrial Environment, PTC-110
Students who wish to register for BioWork must possess a high school diploma or GED and must complete an online information session.
"BioWork: An Introductory Course for Process Technicians, Third Edition," Revised 2020
Lab module or virtual replacements for onsite laboratory exercises
80% attendance
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 80% score.,An approved resume from N.C. BioNetwork or Biotechnology Career Navigator
High school diploma or General Education Diploma
Those with at least a high school diploma or GED who are unemployed, transitioning, especially from other manufacturing sectors, or starting a new career. This course can also be useful for individuals with degrees in biological sciences, chemistry, biochemistry or other fields who want to enter employment in biomanufacturing or pharmaceutical manufacturing and lack the knowledge of the products, regulations and manufacturing methods used in these industries.
Bioprocess Technician 3 or 4, Manufacturing Process Technician I, Operation Specialist
Many employers within Wake County and surrounding counties
Manufacturing process technician
Bioprocess technician
Operation specialist
| Details | Section | Date(s) | Location | Price | Seats | |
|---|---|---|---|---|---|---|
| 329573 | 06/02/26 - 07/28/26 | Eastern Wake Campus | 243.00 | 6 | Register | |
| 329765 | 06/15/26 - 08/12/26 | RTP Campus | 243.00 | 10 | Register | |
| 329781 | 06/16/26 - 08/13/26 | Western Wake Campus | 243.00 | 5 | Register | |
| 330035 | 06/23/26 - 08/11/26 | Southern Wake Campus | 243.00 | 11 | Register |
If you would like to be notified when additional sections become available, please use Wake Tech’s Notify Me service for BTC-3200A7-BioWork: Process Technician Training .
Introduce the basic skills of micropipette operation
Provide experience with a variety of micropipettes commonly encountered in laboratory situations
Discuss and practice techniques used to increase pipetting performance
Provide students with a means to quantify their pipetting skills and measure gains in those skills acquired during the course
Provide an introduction to the dilution of laboratory reagents/samples and the calculations needed to make those dilutions
Introduce the topic of ergonomics as it applies to laboratory procedures and the prevention of workplace injuries
Lecture: The use and function of micropipettes
Lab: Initial micropipetting skill level testing (Artel method)
Lecture: Factors affecting pipetting performance
Lecture: Methods to quantify micropipette performance
Lecture: Guide to dilutions
Lab: Pipetting
Lecture: Tips for better pipetting
Lecture: Ergonomics and micropipetting
Lab: Pipetting and the gravimetric method of measuring pipetting performance
Lab: Practice pipetting with glass, serological and digital pipettes
Lab: Final test of pipetting performance (Artel method)
Open floor for additional questions and feedback
7
Yes
None
None
No
Minimum of a high school diploma/GED or relevant industry work experience. Some exposure to pipetting techniques is beneficial, but is not required.
Study materials, including copies of lecture slides, additional reference material and laboratory exercises, will be provided by the instructor.
N/A
95% attendance
Coefficient of variation (CV) < 1% with micropipettes in two attempts or fewer
N/A
N/A
N/A
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for SEF-79654-Micropipetting Techniques for Precision & Accuracy
.
Explain the regulatory and business rationale for SOPs
Identify FDA expectations
Define at least two approaches for determining what SOPs are needed
Identify factors that support SOP efficacy
Distinguish between methods of presenting SOP content
Analyze the structure and content of an SOP for adherence to the principles of effective SOP construction
Create an SOP utilizing the principles learned in class
Understand how to keep SOPs current
Principles, philosophy, regulatory compliance
Overview and analysis of SOP examples for effectiveness
Create an SOP (or virtual SOP for online classes) per the principles discussed in class
4
No
None
None
No
N/A
Provided with course delivery
Classroom with projection capability
95% attendance
N/A
Biomanufacturing, bioprocessing, pharmaceutical, medical device, cosmetics and other FDA-regulated industry sectors
Quality, Manufacturing, Management
N/A
Quality
Manufacturing
Management
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for SEF-3001ME1-Writing Effective SOPs
.
Attain an understanding of the importance of both internal and external audits
Describe the relationship between FDA auditing activities and cGMP compliance through the Code of Federal Regulations (CFR) for pharmaceuticals
Identify audit findings from real company inspections
Explain do's and don'ts for FDA audits
Distinguish the roles of company representatives during an audit
Relate the importance of proper documentation to provide evidence of compliance with cGMP
Perform an audit of a document used in the biopharmaceutical industry
Reasons for and the importance of audits
What is fair game during an audit
Preparing for an audit
Do's and don'ts
Company responsibilities
Preparation activities and documentation
Review of 483s and warning letters
Things to know about an FDA audit
What to expect
Auditor roles and rights
Auditor responsibilities
Review of sample documentation
4
No
None
None
No
N/A
Provided by BioNetwork
N/A
100% attendance
N/A
Team leaders and supervisors, regulatory personnel, quality control personnel, quality assurance personnel, manufacturing technicians, administrative personnel (scribes), maintenance/engineers
N/A
N/A
Team leaders and supervisors
Regulatory personnel
Quality control personnel
Quality assurance personnel
Manufacturing technicians
Administrative personnel (scribes)
Maintenance/engineers
SEF-79524
SEF-414CL
SEF-211CL
BioNetwork Manager
[email protected]
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for SEF-3001MC1-FDA Audit Preparation
.
Learn the 30 basic rules for technical writing and apply these to scientific examples
Learn the 10 basic guidelines for technical writing that support the technical writing rules and apply these to scientific examples
Complete writing examples/exercises that support the rules and guidelines to become a better writer
Evaluate a sample document for compliance with the rules and guidelines discussed in the class
Organizing writing for SOPs, protocols, internal or external reports, manuscripts, grant proposals, posters, presentations, job applications letters, articles and papers
Understanding readers (your audience) to facilitate better communication
Review of the 30 rules for effective technical writing with examples
Review of the 10 guidelines that assist in achieving effective technical writing, with examples
Topics that enhance your style of writing
How to compose to match your writing style
Recognizing the topic and stress positions in sentences
Recognizing the topic and stress positions in paragraphs
Taking sentences to paragraphs
Planning and laying the foundation for technical writing
6
No
None
None
No
N/A
N/A
N/A
80% attendance
N/A
Pharmaceutical, biomanufacturing, cosmetics, biotechnology positions for quality control, quality assurance, regulatory, engineering, laboratory, manufacturing or any other associate that is required to write their observations or findings for readers to understand
N/A
N/A
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for SEF-3001MG1-Advanced Technical Writing
.
Compare and contrast key differences between microbial fermentation and cell culture in terms of equipment, cell growth, biological products, support systems, nutrients and sterility assurance
Identify components of a pilot-scale fermenter (BioFlo 320), practice monitoring the exponential growth of E.coli by tracking growth parameters such as pH and dissolved oxygen (DO), develop an E.coli growth curve in a batch production record (BPR) using optical density (OD) measurements from a UV/Vis spectrophotometer
Demonstrate the importance of sterility assurance with hands-on activities with both contaminated and healthy cell lines, apply the fundamentals of aseptic technique through Chinese hamster ovary (CHO) cell subculturing (cell passage) inside a biological safety cabinet (BSC)
Monitor cell viability, metabolite quality and osmotic conditions of mammalian cell growth using a cell counter, bioanalyzer and osmometer; observe the impact of cell growth parameters such as pH and oxygen on cell culture maintenance with a blood gas analyzer
Engage with upstream processing single-use technologies such as mixers, containers and tubing; prepare aseptic tubing using a tube welder, single-use tube connectors and sterile filters
Introduction: Fundamentals of upstream processing, fermentation lab (Part I), upstream facilities, equipment and control, tools of the trade, fermentation lab (Part II)
Cell Culture: Cell culture lecture, working with mammalian cells, analyte testing, analyte and metabolite testing lab, single-use technology, aseptic connection demonstration and course wrap-up
16
No
None
None
No
N/A
N/A
N/A
80% attendance
N/A
Bioprocess technicians, bioprocess engineers, manufacturing associates, fermentation technicians, fermentation lab analysts
N/A
N/A
Bioprocess technicians, bioprocess engineers, manufacturing associates, fermentation technicians, fermentation lab analysts
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for SEF-3001MF1-Upstream Processing
.
Recall fundamental topics of downstream processing and define individual steps, such as cell disruption, solid-liquid separation and purification through daily content refreshers and assessments
Explain key differences between filtration, viral clearance and diafiltration. Practice the purification and concentration of proteins through hands-on filtration and diafiltration activities using a batch production record (BPR).
Define the purpose of chromatography and identify different types of chromatography, including ion-exchange chromatography and hydrophobic interaction chromatography. Explain basic protein chemistry and the importance of absorbance for total protein identification.
Identify the importance of column packing and distinguish factors that impact column packing, such as mobile phase and resin selection. Practice column packing calculations and observe a column packing demonstration.
Identify the component of a small-scale chromatography system (ÄKTA Start). Conduct an anion-exchange chromatography (AEX) run through the preparation and A395 analysis of green fluorescent protein (GFP) using the ÄKTA Start Chromatography Systems. Calculate GFP production yield and column performance, such as height equivalent to a theoretical plate (HETP) and asymmetry.
Introduction: Downstream processing overview, filter integrity test, tangential flow filtration (TFF), ÄKTA start ID/filtrate preparation/setup, chemistry review and wrap-up
Chromatography Day: Chromatography operations, column packing, column packing demo, AEX run, single use in DSP and wrap-up
16
No
None
None
No
N/A
N/A
N/A
90% attendance
N/A
Bioprocess technicians, bioprocess engineers, manufacturing associates, fermentation technicians, fermentation lab analysts
N/A
N/A
Bioprocess technicians, bioprocess engineers, manufacturing associates, fermentation technicians, fermentation lab analysts
To be notified when this course becomes available, please use
Wake Tech’s Notify Me service
for SEF-3001MD1-Downstream Processing
.