Biotechnology Certifications

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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.

BioWork Process Technician

Biotechnology Career Field Courses

BioWork: Process Technician Training



The BioWork Process Technician course is designed to provide basic preparation for entry-level process technician jobs in bioprocess manufacturing, pharmaceutical manufacturing and chemical manufacturing. BioWork provides competencies to include understanding the role of a process technician, safety, quality processes, measuring process variables, transforming matter, process technology (including processing equipment and plant utilities), controlling the process, maintaining sterile processes and growing living cells. BioWork graduates are sought-after to become employed in the biopharmaceutical industry in Wake County and surrounding counties. BioWork certification feeds into two Wake Tech degree programs, which means a BioWork graduate can pursue an associate degree at Wake Tech after being hired in the industry.

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

Pharmaceutical Quality and cGMP - Quality methods, standards and practices used in the biomanufacturing industry and how the federal government regulates and enforces them

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

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

Chemical Processes in Biomanufacturing - Introduction to common chemicals in the workplace, basic chemical safety, nature of chemicals, chemical families, chemical reactions and mixtures/solutions

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)

Controlling the Process - Common unit operations, separation methods and equipment, process control parameters and methods, process control instrumentation and manual/automatic control methods

Facilities and the Manufacturing Environment - Facility design and operation considerations, including biopharmaceutical facility regulatory requirements, facility monitoring and maintenance and contamination control concerns/methods

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

Career Development - Workshops and lectures pertaining to resume development, cover letter writing, LinkedIn creation, job-interview skills and the job-application process. Students are encouraged to review the student manual containing career-specific resources and attend career fairs when offered.


Contact Hours

152

CEUs

Yes

Industry Standard, State or National Certification

Certification

Certificate of completion

Website

None

Certification Learning Outcomes/Requirements

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


CE or CU Articulation

BTC-181: Basic Laboratory Techniques or BPM-110: Bioprocess Practices

Prerequisites

Students who wish to register for BioWork must possess a high school diploma or GED and must complete an online information session.

Learning Supplies Needed

"BioWork: An Introductory Course for Process Technicians, Third Edition," Revised 2020

Clinical Site/Special Facilities

Microbiology or chemistry lab

Requirements for Successful Completion

80% attendance
Students must score a minimum of 80% on each unit exam. Students are allowed one retest of each unit exam to reach an 80% score.,An approved resume

Accreditation/Special Approval Requirements

High school diploma or General Education Diploma

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

Process technician

Wake County Need for Industry Positions

Many employers within Wake County and surrounding counties

Industry or Job Titles Related to Training Outcomes for Employment

Process technician

Related Courses

Course Contact Information

Siobhan D'Antonio

[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 .

Sterilization and Controlled Temperature Environment Validation



This course provides participants with an in-depth understanding of steam sterilization as well as the current methods of validation for sterile processes in the pharmaceutical/biotechnology manufacturing environment, including autoclaves and steam-in-place systems, by providing a thorough understanding of sterilization, sterile equipment design, the regulatory requirements associated with sterilization and the methods used to test and validate sterile processes. In addition, this course provides participants with an in-depth understanding of controlled temperature environments, as well as the current methods used to validate them in the biotechnology/pharmaceutical industry. Equipment covered includes validation of incubators, cold rooms, warehouses and freezers.

Course Objectives

The objectives of this course are to provide a thorough understanding of:
• sterilization
• sterile equipment design
• regulatory requirements associated with sterilization
• methods used to test and validate sterile processes
• controlled-temperature environments, including design
• associated regulatory requirements


Outline of Instruction

Day One
Morning session:
Introduction to Steam Sterilization
Autoclave Design
Regulatory Requirements
Acceptance Criteria
Autoclave Testing/Validation
Troubleshooting

Afternoon session:
Field Autoclave Cycle Analysis
Field Autoclave Validation Techniques for Liquid and Dry Goods Loads
Use of the Kaye Validator for Autoclave Validation

Day Two
Morning session:
Steam-in-Place (SIP) Design
Regulatory Requirements
Acceptance Criteria
Autoclave Testing/Validation
Troubleshooting

Afternoon Session:
Field SIP Cycle Analysis
Field SIP Validation Techniques
Use of the Kaye Validator for SIP Validation

Day 3
Morning session:
Control Temperature Unit (CTU) Design
Regulatory Requirements
Acceptance Criteria
CTU Testing/Validation
Troubleshooting

Afternoon session:
Field CTU Cycle Analysis
Field Validation Techniques
Use of the Kaye Validator for CTU Validation


Contact Hours

24

CEUs

Yes

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

Some validation experience or having taken the Basic Concepts of Validation course is preferred.

Learning Supplies Needed

All materials supplied by the Validation Academy

Clinical Site/Special Facilities

N/A

Requirements for Successful Completion

80% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

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

Related Courses

Course Contact Information

Siobhan D'Antonio

[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 .

Microbiology Basics



This course explores basic microbiology concepts that are necessary to know for topics appropriate for various positions within most life science organizations, including quality control associates. Participants learn basic microbiological characteristics that are common in biomanufacturing facilities, as well as the sources of contamination related to personnel that work in these facilities. They also learn the methods for monitoring, collecting and testing of microorganisms that are objectionable in biomanufacturing environments and the techniques to identify them so that these contaminants can be prevented from adversely impacting the product, as well as the methods and regulatory requirements for preventing contamination.

Course Objectives

Understand basic microbiology and properties of bacteria, fungi and mycotoxins that can be harmful in biomanufacturing

Gain an understanding about the human impact on biomanufacturing operations

Learn environmental monitoring and collection methods for effective microbial identification and management of contamination

Understand the various analytical methods and identification techniques for identifying microorganisms so the sources of these contaminates may be prevented

Learn the methods for disinfection, sterilization and control of microbial contamination

Gain an understanding of the importance for aseptic technique in preventing contamination of the product and test articles


Outline of Instruction

Introduction to Industrial Microbiology and Bacteria

Bacteria in Humans

Environmental Monitoring

Quality Control Laboratory Testing

Identification Strategies

Contamination Control


Contact Hours

8

CEUs

Yes

Industry Standard, State or National Certification

Certification

None

Website

None

Certification Learning Outcomes/Requirements

CE or CU Articulation

No

Prerequisites

N/A

Learning Supplies Needed

N/A

Clinical Site/Special Facilities

In-person lab required

Requirements for Successful Completion

80% attendance

Accreditation/Special Approval Requirements

N/A

Intended Audience

Biomanufacturing operations personnel, technicians, process leads, managers and quality personnel

Specific Industry or Business Support Needs

Biomanufacturing operations personnel, technicians, process leads, managers and quality personnel

Wake County Need for Industry Positions

N/A

Industry or Job Titles Related to Training Outcomes for Employment

Biomanufacturing operations personnel, technicians, process leads, managers and quality personnel

Related Courses

Course Contact Information

Siobhan D'Antonio

[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 .