Main Responsibilities and Required Skills for an Aseptic Technician
An Aseptic Technician is a professional who specializes in maintaining sterile conditions in a controlled environment, such as a laboratory or pharmaceutical manufacturing facility. Their primary responsibility is to ensure the cleanliness and sterility of equipment, materials, and processes to prevent contamination and ensure the safety and efficacy of products. In this blog post, we will describe the main responsibilities and the most in-demand hard and soft skills for Aseptic Technicians.
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Main Responsibilities of an Aseptic Technician
The following list describes the typical responsibilities of an Aseptic Technician:
Add
Add, subtract, multiply, and divide in all units of measure.
Assemble
Assemble and disassemble equipment, making sure it is properly cleaned and sterilized.
Assemble lab / production equipment.
Assemble viral and bacterial antigens into final serials.
Assist in
Assist in maintaining adequate supplies in the production area.
Assist in preparation of SOPs and validation of procedures.
Assist in process and system validation activities as required.
Assist in the development and implementation of new processes and procedures for improved aseptic practices.
Assist in updating of batch records, SOPs, and JTC's.
Assist with aseptic filling, lyophilization and capping procedures.
Assist with autoclave operation (sterilization and / or decontamination) as directed.
Assist with Lab Cleaning practices.
Assist with mechanical set up procedures in an aseptic environment.
Assist with mechanical setup procedures in an aseptic environment.
Assist with operation of CIP / SIP systems, as applicable.
Assist with reading and reporting testing results using scientific instruments.
Clean
Clean and sanitize laboratory equipment and work areas.
Clean areas, as applicable, according to specific SOP's.
Clean room gowning required.
Collaborate with
Collaborate with scientists, researchers, and other team members to ensure smooth laboratory operations.
Communicate
Communicate effectively with peers and Team Leader.
Compete
Compete controlled documents and inventory calculations using basic math.
Complete
Complete controlled documents and inventory calculations using basic match.
Complete controlled documents and inventory calculations using basic math.
Complete documentation without error.
Complete documentation without errors.
Conduct
Conduct routine quality control checks to verify the effectiveness of sterilization procedures.
Dispense
Dispense and complete production orders using the SAP inventory system.
Document
Document all procedures, observations, and results accurately and maintain proper records.
Document processes accurately and completely in accordance with SOPs and GMPs.
Document steps accurately and legibly.
Ensure
Ensure all tasks are completed in a GMP compliant and safe manner.
Ensure compliance with regulatory standards and guidelines, such as FDA and GMP.
Execute
Execute all written procedures, to include Batch Records and SOPs.
Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs.
Express
Express a positive attitude and shows respect for co-workers.
Fill
Fill out process specific documents accurately and completely.
Fill vaccines into respective presentations.
Follow
Follow and comply with all financial procedures.
Follow and comply with all site safety procedures.
Follow good GMP practices.
Follow Manufacturing Directions.
Follow specifications required in Process Worksheets and Standard Operating.
Follow specifications required in Process Worksheets and Standard Operating Procedures.
Follow Standard Operating Procedures.
Follow standard operating procedures and protocols for handling, storing, and disposing of sterile products.
Follow strict adherence to safety protocols and wear appropriate personal protective equipment (PPE).
Follow strict aseptic techniques to prevent contamination during experiments or manufacturing processes.
Handle
Handle and dispose of hazardous materials in accordance with safety guidelines.
Handle movement of sterile equipment using practices designed to achieve and ensure.
Identify
Identify and communicate work order issues.
Identify ways to improve the safety culture of the department.
Implement
Implement and maintain production schedules based upon intra-departmental information.
Involve
Involve working with portable and stationary equipment and steam.
Keep
Keep up-to-date with industry regulations and best practices related to aseptic techniques and cleanliness.
Learn
Learn and apply USDA and APHIS requirements to assembly operations.
Learn and comply with SOP's and associated documentation necessary to perform job functions.
Learn and comply with Standard Operating Procedures (SOPs).
Learn and demonstrate an understanding of basic sterilization principles and aseptic technique.
Learn and demonstrate understanding of basic sterilization principles and aseptic.
Learn and demonstrate understanding of basic sterilization principles and aseptic technique.
Learn and practice basic aseptic procedures as per training and SOP's.
Load
Load / unload freeze dryers to complete the lyophilization process when applicable.
Maintain
Maintain accurate inventories of bulk fluids and other components.
Maintain accurate inventory.
Maintain a clean and organized laboratory environment to promote efficiency and safety.
Maintain all associated documentation for operations being performed.
Maintain and edit, as appropriate, departmental cGMP documentation.
Maintain appropriate departmental cGMP documentation.
Maintain appropriate departmental GMP documentation.
Maintain batch record documentation and logs as required by corporation and regulatory agencies.
Maintain equipment and facilities in proper working order.
Monitor
Monitor and document environmental conditions, such as temperature and humidity, to maintain optimal sterile conditions.
Monitor processes and report unusual circumstances and events.
Operate
Operate capping equipment independently.
Operate CIP / SIP equipment.
Operate fill suites independently Utilize Micromax / SCADA system for lyophilizers.
Order
Order raw materials and supplies from warehouse operations.
Participate in
Participate in cross-training within a manufacturing.
Participate in cross training within manufacturing.
Participate in special project teams (i.e., Safety, RFT, Kaizen events).
Participate in training programs to enhance knowledge and skills in aseptic techniques.
Perform
Perform Aseptic processing skills while working in a clean room setting.
Perform basic repairs, maintenance, disassembly, and reassembly of major equipment.
Perform chick embryo origin procedures utilizing associated equipment.
Perform cleaning and sanitizing of production equipment and classified production space.
Perform conversions within the metric system.
Perform downstream processing which may include concentrations, homogenization, and centrifugation.
Perform environmental monitoring.
Perform lab processes using Aseptic Technique in a clean room environment.
Perform Media Preparation functions in ABI manufacturing.
Perform Media Prep functions in ABI manufacturing.
Perform microbial testing and analysis to detect any contamination.
Perform routine daily and weekly cleaning of manufacturing area.
Perform routine environmental monitoring.
Perform routine inspections and maintenance of equipment to ensure proper functioning.
Perform supplemental duties as assigned by supervision.
Perform to ensure compliance with GMPs and SOPs.
Perform viable and non-viable monitoring.
Prepare
Prepare and maintain stock solutions and culture media required for experiments.
Prepare and sterilize instruments, containers, and media for laboratory use.
Prepare equipment, glassware, filters, etc. required for production.
Provide
Provide oversight as necessary.
Reach
Reach with hands and arms.
Read
Read and follow MSDS guidelines.
Review
Review and final approve Manufacturing Directions.
Schedule
Schedule staff and production processes.
Set-up
Set-up, run (filling) and tear down of fill line equipment.
Sterilize
Sterilize medias using heat and filtration methods.
Train
Train and apply cGMP to assigned work.
Train and oversee colleagues.
Train in all functions of the Assembly department and perform other duties as assigned.
Train in Good Manufacturing Practices (GMP's) , then demonstrate understanding and compliance.
Train new aseptic colleagues on environmental monitoring.
Troubleshoot
Troubleshoot equipment malfunctions and perform minor repairs or seek assistance when needed.
Understand
Understand and apply excellent aseptic.
Understand and apply excellent aseptic technique as it relates to serial production.
Understand and apply instructions in written, oral, and / or diagram formats.
Understand and use fill schedule to meet customer's requirements.
Understand, follow, and complete process documentation in support of GMP.
Use
Use appropriate Personal Protective Equipment (PPE) including respirators.
Use inventory control scanners to maintain accurate batch documentation and inventory accuracy.
Utilize
Utilize Micromax / SCADA system for lyophilizers.
Most In-demand Hard Skills
The following list describes the most required technical skills of an Aseptic Technician:
Knowledge of aseptic techniques and cleanroom protocols.
Proficiency in operating and maintaining laboratory equipment, such as autoclaves, incubators, and laminar flow hoods.
Understanding of microbiology principles and microbial testing methods.
Familiarity with sterilization methods, including heat, chemical, and radiation sterilization.
Experience in preparing and maintaining sterile cultures and media.
Competence in following Standard Operating Procedures (SOPs) and protocols.
Proficient in performing microbial identification and enumeration techniques.
Understanding of environmental monitoring and control in sterile environments.
Knowledge of GMP (Good Manufacturing Practices) and FDA regulations.
Experience with aseptic gowning procedures and PPE usage.
Proficiency in conducting quality control tests, including sterility testing and endotoxin testing.
Familiarity with validation and qualification processes for aseptic manufacturing.
Ability to troubleshoot equipment malfunctions and perform minor repairs.
Knowledge of computer systems and software used for data entry and documentation.
Understanding of risk assessment and mitigation strategies in aseptic environments.
Experience in aseptic filling and packaging processes.
Proficiency in aseptic technique training and supervision.
Knowledge of sterile product formulation and compounding.
Familiarity with aseptic process simulations and media fills.
Understanding of cleanroom design and maintenance principles.
Most In-demand Soft Skills
The following list describes the most required soft skills of an Aseptic Technician:
Attention to detail: Aseptic Technicians must have a keen eye for detail to ensure compliance with strict cleanliness and sterilization protocols.
Time management: Aseptic Technicians need to prioritize their tasks and manage their time effectively to meet deadlines and maintain a smooth workflow in the laboratory.
Communication skills: Effective communication is crucial for collaborating with team members, scientists, and researchers to ensure proper understanding of protocols and procedures.
Problem-solving ability: Aseptic Technicians should possess strong problem-solving skills to identify and address any issues or challenges that may arise during sterile processes or equipment operation.
Adaptability: The ability to adapt to changing situations and work in a fast-paced environment is essential for Aseptic Technicians, as they may need to adjust their procedures or protocols based on evolving requirements.
Teamwork: Collaboration and teamwork are vital for Aseptic Technicians to work effectively with others in the laboratory, promoting a cohesive and efficient working environment.
Critical thinking: Aseptic Technicians should possess critical thinking skills to assess and evaluate situations, make informed decisions, and troubleshoot problems in aseptic processes.
Organizational skills: Maintaining a well-organized workspace, keeping track of equipment, and accurately documenting procedures and results are essential for Aseptic Technicians to ensure efficiency and compliance.
Analytical skills: Aseptic Technicians need to have strong analytical skills to interpret data, identify trends or anomalies, and make data-driven decisions for maintaining sterile conditions.
Attention to safety: Aseptic Technicians must prioritize safety at all times, following safety protocols and guidelines to protect themselves, their colleagues, and the integrity of the sterile environment.
Conclusion
Aseptic Technicians play a vital role in maintaining sterile conditions and ensuring the safety and quality of laboratory experiments and manufacturing processes. They are responsible for executing aseptic techniques, performing sterilization procedures, maintaining equipment, and adhering to strict protocols. The most in-demand hard skills for Aseptic Technicians include knowledge of aseptic techniques, proficiency in operating laboratory equipment, and understanding of microbiology principles. Additionally, soft skills such as attention to detail, time management, and communication skills are highly valued in this profession. By possessing the necessary technical and soft skills, Aseptic Technicians contribute to the successful and safe operation of laboratories and sterile environments.
