Introduction
The Need for Biomanufacturing Skill Standards
The Ten Biomanufacturing Occupations
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What Are Skill Standards?
Skill standards are an organized listing of the pieces of work performed by people in a specific occupation or a cluster of occupations, the academic knowledge and technical knowledge and skills needed to do this work, and the proficiency level of knowledge/skills and performance required to accomplish the work to a satisfactory level. Both the content and the proficiency level of skill standards must be determined by the end user, employer, or group of employers in the industry for which the work is to be done.
Industry skill standards usually break down the work into large “duty” or “function” areas,
which are further subdivided into more specific “tasks.” At
its most precise level, a set of skill standards will be subdivided into
very specific “competencies,” the smallest units of work
for a given occupation or cluster of occupations. The standards also
usually include a list of tools and equipment used by people in their
occupation, and traits, behavioral qualities, and attributes considered
necessary or desirable for that type of work.
As mentioned, industry skill standards must come from industry, that is, they must embody an accurate picture of the work that is done; the knowledge, skills, and qualities required for that work; and some indication of the level of achievement required to perform the work proficiently. The standards may be obtained from managers in the industry; however, we and others have found that the information is most accurate and precise when provided by the people who actually do the work.
Various methods have been used to obtain skill standards information, including surveys, interviews, focus groups, and workshops, in which knowledgeable employees in similar occupations work together. Later in this introduction, we describe the method used to obtain the information for the biomanufacturing skill standards.
The Need for Biomanufacturing Skill Standards
Industry skill standards are needed to guide educators and trainers in colleges, high schools, companies, private training programs, and other venues to plan training programs, courses, curricula, and other learning experiences to prepare people to meet the real performance needs for an industry’s workforce. Standards help ensure that what is learned is what industry has said their employees will need for work, thereby creating a secure fit between technical education and employment and career opportunities.
The U.S. biotechnology industry is now well into its third decade. As
it has matured, the industry has enlarged from its early, nearly total
emphasis on basic and then applied research, to development of products,
and now, increasingly, to the production of consumer-ready products that
have been tested and approved by the FDA. The biomanufacturing component
of the biotechnology industry is about to expand significantly, especially
in the Northeast (West Coast companies have been manufacturing products
for a longer time), as more and more products pass through trials and
are approved for consumer use.
In response to the growth of the industry in the 1990s, Education Development Center, Inc. (EDC), led the development of the national Bioscience Industry Skill Standards. These standards contain the duties and tasks performed by a number of technician-level bioscience occupations in research and development, clinical labs, and manufacturing, as well as the tools and equipment used and the behavioral attributes needed for this work. These industry-based standards have been used for nearly a decade by education institutions, companies, government, and other organizations as a basis for developing training programs, curricula, human-resources policies, and economic development.
The current and continuing expansion of biomanufacturing is requiring education institutions to prepare people specifically for employment in that sector of the industry. The projections vary, but all data shows that the need for people trained to meet the requirements of a range of biomanufacturing occupations is growing and will continue to grow at an increasingly rapid pace during coming years as more biotechnology companies move into manufacturing. A large portion of these new jobs will be for technicians. This situation necessitates the creation of skill standards that define what work these technicians do in a range of occupations and what knowledge, skills, and behaviors they need to succeed in these jobs. In response to this need, we have created biomanufacturing skill standards for the following occupations:
- Chemistry QC technician
- Environmental health and safety technician
- Facilities technician
- Instrumentation/Calibration technician
- Manufacturing technician (downstream)
- Manufacturing technician (upstream)
- Microbiology QC technician
- Process development associate
- QA documentation coordinator
- Validation specialist
Development of the Standards
These standards were developed as part of a project, supported by the National Science Foundation, to provide technical support for the biotechnology industry, education institutions (community colleges and some high schools and 4-year colleges), and other organizations and partnerships in the Northeast region of the United States. The major partners in this project were New Hampshire Community Technical College (NHCTC) and EDC. The development of the standards took place from spring through winter 2004. It began with workshops in the spring, followed by surveys, distributed in the summer and fall. The results of the surveys were analyzed during early winter.
Job Analysis Workshops
The basic information for the standards was obtained in two 2-day workshops,
held in May 2004, in which a total of 28 technicians and supervisors
representing
10 biomanufacturing occupations participated. The approach
used was a modified DACUM (Designing a Curriculum) process. The participants
worked in teams, each representing one occupation, to identify the
duty
areas (functions), tasks performed, specific competencies required, tools
and equipment used, and behavioral traits needed to perform their work.
They also identified, for the academic knowledge required, whether
the
knowledge needed to be only at a basic (B) level (less than six months
training and/or experience), intermediate (I) level (less than two
years
training and/or experience) or advanced (A) level (more than two years
training and/or experience), and whether the knowledge needed was conceptual
(C) or practical/applied in nature. The participants came from 12 biotechnology
companies from five states in the Northeast.
The end products of the workshops were 10 charts, one for each occupation, that included all of the information listed above.
Surveys
Because the information obtained in the workshops represented only a small
sample of people, we needed to obtain a larger sample from a broader number
of companies to validate the workshop results. We also wanted to obtain
additional information to assist educators in using the standards to develop
programs, courses, and curricula.
We reformatted the charts into 10 separate surveys,
and e-mailed them to over 170 biomanufacturing technicians, supervisors,
and managers in a number of biotechnology companies in the Northeast
and
Mid-Atlantic regions. We received 57 completed surveys from 15 companies
in six Northeast and Mid-Atlantic region states (see Demographic
Summary).
Respondents were asked to rate the importance of each of the competencies
on a 4-point scale, and to indicate, for each competency,
the amount of training and/or experience required to perform at a proficient
level. The answers to these questions, which are summarized in the Results section of this site, provide additional information for people developing
programs, courses, and course
sequences.
We analyzed the survey responses and made some revisions to the workshop
charts based on those responses. If all or most of the respondents indicated
that a particular competency, or occasionally a whole task, ranked very
low in importance, we deleted it from the chart. Likewise, if almost no
one ranked a particular competency, we concluded that that competency
was not performed enough to be included, and we deleted it. We did, however,
keep competencies that were ranked by a number of people as needing very
little training or experience. These are sometimes important competencies,
but usually ones that can be learned very quickly, either as part of an
introductory-level course or on the job. The charts in this booklet reflect
all of these revisions.
How to Use the Standards
The standards provide much information for developing courses, course sequences, programs, curricula, and teacher development in community or technical colleges, four-year colleges, high schools, and other education institutions. Companies also can use them to develop in-house training, curricula, and human resource guidelines. The standards contain the following information for each of 10 biomanufacturing occupations:
Functions (large pieces of work) conducted by technicians in this occupation.
Tasks (smaller pieces of work within each function) that the technicians
perform.
Competencies (the most specific pieces of work within each task) that
technicians perform.
The functions, tasks, and competencies provide increasingly specific information
about the knowledge and skills people must learn to become proficient
in a given occupation.
Fields of academic knowledge used by technicians in this occupation: Provides information about what academic courses or study areas people should learn prior to, or in conjunction with, their technical training to understand the conceptual science underlying the work they will be doing.
The level of proficiency: Provides information about “how much” academic knowledge is required in each academic discipline for that occupation, for example, whether the required proficiency level can be reached in several lessons, one course, or a series of courses.
Conceptual (familiarity with underlying science) or practical mastery: Indicates the amount and type of training/experience a person will need. This measure can help educators decide, for example, whether learning can be achieved solely in the classroom or if it requires lab-based and/or work-based learning as well.
Types of technical knowledge and skills used by technicians in this work: Provides information about what lessons, courses, course sequences, and workplace experiences people need to take, and about the curricula to be developed for each of these learning experiences, to bring them to the proficiency levels required to do the work in this occupation.
Tools and equipment used by technicians in this occupation: Provides educators with information about what kinds of lab experiences and other workplace-related learning people must master to work in this occupation.
Traits, characteristics, and behaviors considered necessary for people working in this occupation (which workshop participants felt apply equally to all of the biomanufacturing occupations): Provide information about some general technical, cognitive, and interactive skills people need to master as part of their learning. These skills provide ideas both for curriculum content and for pedagogy (e.g., following industry SOPs, keeping authentic lab notebooks, having students work in teams, analyzing problem-based scenarios or case studies, taking turns being group leaders).
Degree of importance ranking (i.e., criticality and frequency) of each of the competencies obtained from the surveys: Provides a combination of information about “how critical” each competency is to the occupation and “how frequently” it is likely to be used. When designing a curriculum, course, or course sequence, an educator can use the average rating of each competency (contained in the Results section of this site) to decide how much it should be emphasized. The lower the average rating score, the more important it was judged to be. So, for example, a competency rated 1.1 (of a 4-point range) was considered to be “critical to the job,” whereas a competency rated 3.9 was considered to be “an asset, but not necessary.” Obviously, competencies rated as “critical” or “very important” would be emphasized in a curriculum, coursework, and perhaps in work-based learning. A competency rated a 3 would be emphasized less, and one rated 4 might not be included at all.
Some competencies were only rated by a few respondents (of the group responding to that occupation survey). However, if those people rated the competency highly—a 1 or 2 (which can be seen in the Appendix tables)—then we assumed not everyone in all settings does that work, but for those who do, it is important.
Amount of training and/or experience considered necessary to prepare a person to be proficient in each competency in this occupation (1=more training/more experience, 2=more training/some experience, 3=some training/more experience, 4=some training/some experience, 5=little training little experience): Ranking provides information about when in coursework or a training program a particular competency should be taught. A competency with a majority ranking of “little” may be important for people to learn, but may be lower-skilled—something that can be learned in an introductory course, a short course, or even on the job.
A competency with a majority ranking of “some” might be appropriately taught in a mid-level course, where more experience or prerequisite knowledge is required. A competency with a majority ranking of “more” requires more experience or prerequisite knowledge and probably should be taught in a higher-level course or learned in preparation for advancement to a supervisory level.
In the document prepared for use by educators and companies, we included the following suggestions:
When planning courses and curricula, it is important for educators to work with local industry, using these standards to determine which of the tasks and competencies are important in your local industry (the most likely employers of local education institution graduates).
Where in a course of learning particular competencies should be taught is best determined by educators studying the skill standards with local industry representatives. This will ensure a good fit that will benefit everyone.
Each of these pieces of information can be used to help with program and curriculum development.
The Ten Biomanufacturing Occupations
We chose to focus on 10 biomanufacturing occupations that were identified by companies in the industry as the primary occupations employing technicians. The descriptions of the occupations were provided by the Massachusetts Biotechnology Council , which commissioned the written descriptions from the Massachusetts Department of Higher Education.
We were unable to develop skill standards for one biomanufacturing occupation that employs technicians—aseptic fill technician—because there were few of these technicians employed in all of the companies we contacted, and they were in such demand they could not be given time off to participate in the workshops during the time period of our study. We recommend that additional efforts be made to develop skill standards for the occupation of aseptic fill technician.
Chemistry QC Technician
Performs a variety of inspections, checks, tests, and sampling procedures
for the manufacturing process according to standard operating procedures
(SOPs). Performs in-process inspection and documents results. Monitors
critical equipment and instrumentation. Writes and updates inspection
procedures and checklists as necessary. Requires knowledge of current
good manufacturing practices (GMPs).
Environmental Health & Safety Technician
Responsible for water and air sampling and monitoring, processing permits,
calibration and maintenance of scientific monitoring, data collection
and routine analysis. Installs and services recording instruments; maintains
physical stations where data is collected, inspects stations records to
ensure quality assurance and preventative maintenance procedures are conducted
properly. May conduct special studies such as toxic water monitoring,
biological monitoring, and air/water pollutant investigations and recommend
corrective actions. Records and maintains periodic data logs and information
files. Typically works from drawings, specifications, diagrams, schematics,
and specific verbal and written instructions. Working knowledge in sampling,
data collection and analysis, pollution complaint investigations, instrument
calibration, and environmental law, or experience in assessing environmental
conditions is desirable.
Facilities Technician
Performs daily monitoring, repair, and preventive maintenance activities
on critical systems and facility equipment. Troubleshoots, installs, and
modernizes new and existing systems, including refrigeration equipment,
water systems, HVAC systems, and electrical systems. Documents repairs,
adjustments, and replacement of equipment and/or components per GMP standards.
May also provide input and corrections to SOPs and assist engineering
in the evaluation of new equipment or technology. Knowledge of major trades,
such as carpentry, electrical, plumbing, and HVAC refrigeration, including
the ability to interpret blueprints, technical manuals, and specifications,
is required.
Instrumentation/Calibration Technician
Maintains, tests, troubleshoots, and repairs a variety of circuits, components,
analytical equipment, and instrumentation. Calibrates instrumentation
and performs validation studies. Specifies and requests purchase of components.
Analyzes results and may develop test specifications and electrical schematics.
Performs continuous monitoring of equipment status, condition, and location.
Prepares required documentation for the recording and notification of
events and changes related to equipment such as calibration certificates,
deviations, out of tolerances, and installation reports.
Manufacturing Technician—Downstream
Responsible for setting up area operations, performing according to SOPs,
and following electronic work instructions in accordance with a GMP environment
to manufacture biopharmaceutical drug substances. Responsibilities include
cleaning-in-place (CIP) and sterilizing-in-place (SIP) of equipment, column
chromatography, ultrafiltration, diafiltration, conducting protein purification
operations, monitoring control devices, and executing any other related
operations pertaining to the process area. Also maintains records to comply
with regulatory requirements and assists with in-process testing.
Manufacturing Technician—Upstream
Responsible for assisting manufacturing in specific product-related operations
in cell culture and growth. Operates and maintains production equipment
as it relates to cell culture (i.e., cell harvests and separation operations).
Also performs fermentation. Operates and maintains production equipment
related to fermentation (e.g., fermenters, bioreactors, centrifuges).
Weighs, measures, and checks raw materials to assure proper ingredients
and quantities. Prepares media and buffer components. Maintains records
to comply with regulatory requirements and assists with in-process testing.
Microbiology QC Technician
Performs routine microbiological testing of raw materials, in-process
samples, and finished formulations according to SOPs. Conducts routine
environmental monitoring of GMPs, manufacturing areas, equipment and processes
according to established procedures. Calibrates and maintains microbiology
laboratory equipment. Compiles and analyzes data for documentation of
test results and prepares related reports. Revises and updates SOPs as
necessary.
Process Development Associate
Responsible for evaluating, improving, and scaling-up manufacturing processes
in order to improve product yield and reduce overall costs of production.
Executes small-to-medium scale production work, which may involve cell
culture, fermentation, purification, and/or chromatography. Additionally,
assists with maintenance of production equipment. May research and implement
new methods and technologies to enhance operations and may assist in validation
of production processes.
QA Documentation Coordinator
Responsible for providing clerical and administrative support related
to documentation system requirements/maintenance. Audits all documentation
manuals to assure they are accurate and up-to-date, and available to appropriate
personnel. Maintains filing of all master documents and assists in all
microfilming and archiving activities.
Validation Specialist
Responsible for developing and recommending validation strategies and
designing studies for the purpose of providing documented evidence that
a system, equipment, method, or process has been validated. Conducts and
processes qualification programs, writes detailed protocols and reports
to document the validation of systems/equipment, and provides validations
support for facility and utility expansion, compliance upgrades, etc.
Develops and implements solutions to validation issues. Knowledge of current
industry practices and GMP requirements related to validation tasks is
required.
