BioWork Process Technician
BioWork is a 136-hour, non-credit certificate course that can lead to an entry-level position as a process technician. The certificate provides course credit that can be put toward an associate degree in Biotechnology or Biopharmaceutical Technology.
BioWork is intended for high school graduates and those who want to pursue a career in the biopharmaceutical industry. Those already in the industry can earn continuing education units (CEUs) for the course.
"Of all the teachers and courses I've taken, I would say that BioWork impacted my life the most. I went from minimum wage to making a great living surrounded by people who actually enjoy coming to work for a company that actually cares."
-Ryan Kennedy, Merck employee
To be eligible for the BioWork program, you must either have a high school diploma, equivalency or some form of post-secondary education, or you must take math and reading placement tests at Wake Tech. You also must complete the online BioWork information session.
- Program: Eight units of study designed by industry and directly related to biopharmaceutical technology
- Costs: $180, plus applicable administration fees of $18. For the Fall 2024 semester, the textbook can be purchased at the Southern Wake Campus Bookstore for about $110, plus taxes. Instructions on how to obtain the student manual will be provided in the welcome letter by your instructor a few weeks prior to the class starting.
- Duration: Depends upon the section chosen to attend
- Class format: In-person, online or hybrid; day or evening
- Location: Western Wake Campus or RTP Campus (also online activities)
BioWork offers the following benefits for students:
- Teaching expertise of industry veterans
- Teamwork and problem-solving activities
- Networking opportunities linked to career-building and job search
- Resume support and interview practice
- Optional state certification exam for process technicians
NOTE: Participation in online classes through Microsoft Teams meetings, and access to Blackboard, the online interface for the course, will require a student's access to a laptop or desktop computer. A tablet or cellphone will not work for Blackboard functions or much of the Microsoft Teams meetings material. Details on these classes on the online meeting days and times can be found by clicking on the "Details" button for each class section.
Questions? Email [email protected].
Industry-recognized credential: BioWork Process Technician Certificate
Complete course in: Four months or less
Financial assistance available
Don't have enough money to pay for a course? Right now, Wake Tech's Propel program offers scholarships that cover the cost of registration and fees.
NOTE: The Propel Scholarship Application is currently closed and will reopen July 1.
Other scholarships to cover half of the course cost may be available. For more information, contact Workforce Continuing Education Financial Resources and Student Support.
BioWork Process Technician Training Courses
BioWork: Process Technician Training
Course Objectives
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.
Outline of instruction
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.
Contact Hours
136
CEUs
1
Industry Standard, State or National Certification
Partnership for Biotechnology Workforce Training - Process Technician Examination
CE or CU Articulation
Bioprocess Practices,BPM110 and Industrial Environment, PTC110
Prerequisites
Students who wish to register for BioWork must possess a high school diploma or GED, must complete an online information session.
Text and Supplies Needed
BioWork: An Introductory Course for Process Technicians, Third Edition, Revised 2020
Clinical Site/Special Facilities
Lab Module or Virtual replacements for onsite laboratory exercises
Requirements for Successful Completion
80% attendance"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%"," An approved resume from NCBioNetwork or Biotechnology Career Navigator"
Accreditation/Special Approval Requirements
N/A
Intended Audience
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.
Specific Industry or Business Support Needs
Bioprocess Technician 3 or 4, Manufacturing Process Technician I, Operation Specialist
Wake County Need for Industry Positions
Many employers within Wake County and surrounding counties
Industry or Job Titles Related to training Outcomes for Employment
Manufacturing Process Technician
Bioprocess Technician
Operation Specialist
| Details | Section | Date(s) | Location | Price | Seats | 312658 | 08/15/25 - 12/15/25 | Online | 180.00 | 2 | Register |
|---|---|---|---|---|---|---|
| 312477 | 08/18/25 - 12/15/25 | Southern Wake Campus | 220.00 | 15 | Register | |
| 312630 | 08/18/25 - 12/15/25 | Western Wake Campus | 220.00 | 17 | Register | |
| 312637 | 08/18/25 - 10/14/25 | Western Wake Campus | 220.00 | 14 | Register | |
| 312655 | 08/18/25 - 12/15/25 | RTP Campus | 220.00 | 12 | Register | |
| 312472 | 08/18/25 - 12/15/25 | Southern Wake Campus | 220.00 | 19 | Register | |
| 312644 | 10/15/25 - 12/17/25 | Western Wake Campus | 220.00 | 18 | Register |
If you would like to be notified when additional sections become available, please use Wake Tech's Notify Me service.
Aseptic Processing I
Course Objectives
Develop an understanding of the role aseptic processing plays in the manufacture of pharmaceuticals.
Gain a basic understanding of microbiology in the context of parenteral drug manufacturing.
Gain hands-on experience with cleaning and disinfection of aseptic processing areas.
Develop an understanding of the principal sterilization methods for aseptic manufacturing.
Gain hands-on experience in aseptic gowning.
Outline of instruction
Day 1: Microbiology and Cleanrooms
a. Introductions
b. Lecture: Why Aseptic Processing?
c. Overview of CGMPs and GDPs
d. Cleanroom designs and controls (Tour)
e. Lab: Cleaning of Aseptic Areas- Facility cleaning and selected slides (Lecture)
f. Lab- Cleaning the cleanroom/ BSCs
Day 2: Environmental Monitoring
a. Lecture: Microbiology Basics
b. Lecture: Environmental Monitoring
c. Lecture: Microbiology Basics
d. Labs: Environmental Monitoring (Finger Plates, Body Swabs, Contact Plates, Air Sampling for Viables, Air Sampling for Particulates)
e. Lab: Disinfectant Experiment
f. Lab: Component Preparation
Day 3: Sterile product equipment and component preparation sterilization section
a. Lecture: Aseptic Gowning and Cleanroom Behaviors
b. Video: Aseptic Gowning
c. Lab: Filtration in cleanroom
d. Lab: Read Disinfectant plates
Day 4: Lab and Lecture Review (Cleanroom Behaviors and Aseptic Technique Critique, Filtration Results, Gowning)
a. Lab: Solution preparation lecture
b. Lecture: principles of filtration
1 Lab: Review and Discuss Results of Microbiological Data
2 Q&A for AP I
3 Course Evaluations
4 Final Quiz and Course Wrap-up
Contact Hours
24
CEUs
1
Industry Standard, State or National Certification
None
CE or CU Articulation
No
Prerequisites
None
Text and Supplies Needed
Gowning materials, lecture materials, disinfectants, agar plates (finger plates, body swabs, contact plates) Air sampler (viable, and particulate sampling).
Clinical Site/Special Facilities
Capstone or RTP cleanroom facility
Requirements for Successful Completion
90% attendance"Minimum score of 80% on final quiz in two attempts or fewer. "
Accreditation/Special Approval Requirements
N/A
Intended Audience
Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel; persons desiring entry into the Biotechnology field
Specific Industry or Business Support Needs
Aseptic Processing Technician, Bioprocess Technician, Gene Therapy Operation Specialist, Lab Technician, QC or QA personnel.
Wake County Need for Industry Positions
https://www.ncworks.gov/vosnet/jobbanks/jobdetails.aspx?enc=9B8/uT7EfbE…
Industry or Job Titles Related to training Outcomes for Employment
Bioprocess Technician
Lab Technician
Gene Therapy Operation Specialist
Manufacturing Associate
Related Courses
BTC-3300C4
BTC-3200A7
Course Contact Information
Cynthia Lawrence
919-335-1037
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Aseptic Processing II
Course Objectives
Gain familiarity with aseptic manufacturing practices and the controls used to provide and maintain the necessary environment for the manufacturing of parenteral products, including process simulations. Aseptic technique will be a primary focus.
Perform aseptic process simulations within LAF's, BSC's and Barrier Isolators.
Compare open-system to closed-system aseptic processes utilizing tube welder, aseptic connections and single-use disposable vessels.
Conduct an investigation into aseptic processing issues and write a CAPA report based on observations.
Outline of instruction
Day 1 -
a. Classroom: Aseptic Technique Review
b. Classroom: Microenvironments
c. Lab: Micropipetting / Automated Fill Line Demonstration
d. Lab: Aseptic Connections
e. Classroom: Product Release testing
f. Lab: Particulate Release Testing / Steritest
g. Classroom: Regulatory Aspects of Aseptic Processing
Day 2 -
a. Classroom: Process Simulation and Media Fills
b. Lab: Media Fill Aseptic Simulation (Manual)
c. Lab: Cupric sulfate in Isolator / BSC Cell Culture Activity
Day 3 -
a. Classroom: Discussion of Aseptic Technique / gowning from Day 2 Lab
b. Classroom: Biosafety Levels and Precautions
c. Classroom: Endotoxins
d. Video: Endotoxins--Charles River Laboratories
e. Lab: Endotoxins--PTS Unit
f. Classroom: Water Systems
g. Lab: Gram Stains / Serial Dilution of Media in an Isolator
Day 4 -
a. Classroom: Discussion of Aseptic Technique from Day 3 Lab Activities
b. Classroom and Lab: Lyophilization / DSC / Freeze-drying microscopy
c. Classroom: History of Aseptic Processing
d. Classroom: Investigations Utilizing Fish-Bone Analysis
e. Review / Q&A
f. Evaluations
g. Final Written Test and Lab Practicum
Contact Hours
24
CEUs
1
Industry Standard, State or National Certification
None
CE or CU Articulation
No
Prerequisites
NONE
Text and Supplies Needed
Micropipettes, Media, Culture, Faculty prepared presentations, Gram stain slides, biosafety cabinet, videos, gowning supplies, Laminar Air Flow Hood, Barrier Isolators, chemical and media supplies.
Clinical Site/Special Facilities
Capstone, or RTP cleanroom facility, labs, and classroom.
Requirements for Successful Completion
90% attendance"Successful completion of lab practicum and final written test. "
Accreditation/Special Approval Requirements
N/A
Intended Audience
Biopharmaceutical technicians, biopharmaceutical supervisors, QA and QC personnel; persons desiring entry into the Biotechnology field
Specific Industry or Business Support Needs
Bioprocess Technician, Manufacturing Associate, QC & QA Validation, Lab technician, Gene Therapy Operation Specialist,
Wake County Need for Industry Positions
https://www.ncworks.gov/vosnet/jobbanks/jobdetails.aspx?enc=9B8/uT7EfbE…
Industry or Job Titles Related to training Outcomes for Employment
Bioprocess Technician
Manufacturing Associate
QC & QA Validation
Lab technician
Gene Therapy Operation Specialist
Related Courses
BTC-3200A7
BTC-3300C4
BTC-3300E4
Course Contact Information
Cynthia Lawrence
919-335-1037
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Clean Room Gowning
Course Objectives
Explain the need for aseptic gowning in aseptic processing and maintaining the gowning integrity.
Review common gowning mistakes.
Describe the different stages of aseptic gowning.
Understand the appropriate procedure for sterile gloving and aseptic gowning.
Review the various aseptic gowning techniques used in industry.
Identify the phases for developing an aseptic gowning qualification program.
Outline of instruction
1. Gowning terminology
2. Improper gowning citations.
3. Sterile gloving
4. Aseptic gowning
5. personnel monitoring
Contact Hours
4
CEUs
1
Industry Standard, State or National Certification
None
CE or CU Articulation
No
Prerequisites
NONE
Text and Supplies Needed
Computer and internet access - online course, or gowning supplies, classroom
Clinical Site/Special Facilities
N/A for online, or Capstone, Western Wake, RTP lab space.
Requirements for Successful Completion
attendance"Demonstrate Gowning Proficiency."
Accreditation/Special Approval Requirements
N/A
Intended Audience
New and incumbent bio manufacturing employees
Specific Industry or Business Support Needs
Bioprocess Technician, Gene Therapy Operation Specialist, Production Operators, Quality Assurance, Quality Control, Maintenance Personnel, Process Engineers, FDA Auditors, Supervisors, Manufacturing Technicians,
Wake County Need for Industry Positions
https://www.ncworks.gov/vosnet/jobbanks/jobdetails.aspx?enc=9B8/uT7EfbE…
Industry or Job Titles Related to training Outcomes for Employment
Bioprocess Technician
Gene Therapy Operation Specialist
Production Operators
Quality Assurance
Maintenance Personnel
Process Engineers
FDA Auditors
Related Courses
BTC-3200A7
BTC-3300C4
BTC-3300D4
Course Contact Information
Cynthia Lawrence
919-335-1037
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Writing Effective SOPs
Course Objectives
Explain the regulatory and business rationale for SOPs.
Identify FDA expectations.
Define at least 2 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 based on the principles learned in the class.
Understanding contemporaneous SOP's and meaningful SOP churn.
Outline of instruction
Lecture - principles, philosophy, regulatory compliance
Examples - overview and analysis of SOP examples for effectiveness
Writing exercise - creation of an SOP (or virtual SOP for online classes) per the principles discussed in class.
Contact Hours
4
CEUs
1
Industry Standard, State or National Certification
None
CE or CU Articulation
No
Prerequisites
NONE
Text and Supplies Needed
Provided with delivery of the course
Clinical Site/Special Facilities
Classroom with projection capability
Requirements for Successful Completion
attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Biomanufacturing, Bioprocessing, Pharmaceutical, Medical Device, Cosmetics, and other FDA regulated industry sectors.
Specific Industry or Business Support Needs
Bioprocess Technician, Data Quality Control, Quality Assurance Specialist, Risk Management, Process Engineer
Wake County Need for Industry Positions
https://www.ncworks.gov/vosnet/jobbanks/jobdetails.aspx?enc=9B8/uT7EfbE…
Industry or Job Titles Related to training Outcomes for Employment
Data manager
QA Manager
Subject Matter Expert
Process Engineer
Bioprocess Technician
Risk Assessment Manager
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Current Good Manufacturing Practices
Course Objectives
Define the elements of current Good Manufacturing Practices (CGMP) for biomanufacturing and pharmaceutical production.
Explain how CGMP helps regulated companies comply with the law: Part 21 of the Code of Federal Regulations (21 CFR 211).
Understand the importance of current Good Documentation Practices (CGDP) for pharmaceuticals and Part 11 of the Code of Federal Regulations (Electronic Record Keeping).
Recognize the consequences of failing to comply with CGMP.
Outline of instruction
The mission of the FDA
The quality assurance role
Personnel and organization
Buildings and facilities
Equipment
Control of components, drug product containers, and closures
Production and process controls
Packaging and labeling
Holding and distribution
Laboratory controls
Records and reports
Return and salvaged drug products
Complaints and recalls
Good Documentation Practices (GDP)
Computer systems (Part 11)
Regulatory enforcement
Contact Hours
4
CEUs
1
Industry Standard, State or National Certification
None
CE or CU Articulation
No
Prerequisites
N/A
Text and Supplies Needed
Provided by NC BioNetwork
Clinical Site/Special Facilities
N/A
Requirements for Successful Completion
attendance
Accreditation/Special Approval Requirements
N/A
Intended Audience
Manufacturing Technicians, Team Leaders and Supervisors, Quality Control Personnel, Quality Assurance Personnel, Maintenance/Engineers
Specific Industry or Business Support Needs
N/A
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to training Outcomes for Employment
Manufacturing Technicians
Team Leaders and Supervisors
Quality Control Personnel
Quality Assurance Personnel
Maintenance/Engineers
Related Courses
SEF-414CL
SEF-79524
Course Contact Information
Cynthia Lawrence
919-335-1037
[email protected]
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
Micropipetting Techniques for Precision and Accuracy
Course Objectives
• To introduce the basic skills of micropipette operation
• To provide experience with a variety of micropipettes that will be commonly encountered in laboratory situations
• To discuss and practice techniques used to increase pipetting performance
• To provide students with a means to quantify their pipetting skills and measure gains in those skills acquired during this course
• To provide an introduction to the dilution of laboratory reagents / samples and the calculations needed to make those dilutions
• To introduce the topic of ergonomics as it applies to laboratory procedures and the prevention of workplace injuries
Outline of instruction
Course Introduction
1.1. Lecture: Use and function of micropippetors
1.2. Lab: Testing of initial micropipetting skill levels (Artel method)
1.3. Lecture: Discussion of factors affecting pipetting performance
1.4. Lecture: Discussion of methods to measure micropipette performance
1.5. Lecture: Guide to Dilutions
2. Technical Instruction
2.1. Lab: Practice micropipetting
2.2. Lecture: Tips for better pipetting
2.3. Lecture: Ergonomics and Micropipetting
2.4. Lab: Practice pipetting and Gravimetric method of measuring pipetting performance
2.5. Lab: Practice pipetting with glass, serological, and digital pipettes
3. Assessment
3.1. Lab: Final test of pipetting performance (Artel method)
4. Conclusions and Final Discussion
4.1. Open floor for additional questions and feedback
Contact Hours
6
CEUs
1
Industry Standard, State or National Certification
None
CE or CU Articulation
No
Prerequisites
None
Text and Supplies Needed
Micropipettes, different pipets, training handouts, different solutions, micropipette tips, beakers, test tubes, test tube racks, straws, colored water, and ARTEL unit and unit supplies,
Clinical Site/Special Facilities
N/A
Requirements for Successful Completion
attendance" Coefficient of variation (CV) < 1% with micropipettes in two attempts or fewer"
Accreditation/Special Approval Requirements
N/A
Intended Audience
Bioprocess technicians, lab technicians, QC lab technicians, and environmental monitoring technicians
Specific Industry or Business Support Needs
N/A
Wake County Need for Industry Positions
N/A
Industry or Job Titles Related to training Outcomes for Employment
Laboratory Technician
Bioprocessing Technician
No active courses available at this time.
To be notified when this course becomes available, please use
Wake Tech's Notify Me service.
