Aseptic Technician, Level 1

As an Aseptic Technician I, you will be responsible for performing various tasks related to the aseptic filling of pharmaceutical products in ISO Class 7 rooms with ISO 4 and 5 filling hood systems. You will work closely with other members of the production team to ensure that all products are manufactured in accordance with established GMP guidelines and meet the company's high standards of quality, safety, and efficacy. An Aseptic Technician I works under close supervision with minimal latitude for independent judgment.

• Perform aseptic filling of pharmaceutical products using ISO Class 7 clean rooms with ISO 4 and 5 filling hood systems.
  
  
• Operate equipment, including filling machines, autoclaves, and sterilizers, according to established protocols and SOPs.
  
  
• Perform a variety of processing duties according to Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in the Manufacturing Department, including but not limited to cleaning and recovery of classified areas and workspaces, component preparation, weighing raw materials, compounding/formulation, filtration of solutions, aseptic filling, inspection, labeling, and packaging.
  
  
• Prepare the clean room, including materials and resources, with the goal of eliminating errors and working in accordance with Current Good Manufacturing Practices (cGMP).
  
  
• Monitor and maintain aseptic conditions in the filling room, including cleaning and disinfecting equipment and surfaces.
  
  
• Follow all safety procedures and guidelines, including wearing appropriate personal protective equipment (PPE).
  
  
• Complete all necessary documentation and records, including batch records and logbooks, according to GMP guidelines.
  
  
• Participate in training programs to maintain and improve skills and knowledge of aseptic techniques and procedures.
  
  
• Perform all other duties as assigned by supervisor or management.
  
  

• High school diploma or equivalent required.
  
  
• One year of experience in a manufacturing environment.
  
  
• Experience using Microsoft Office Suite.
  
  

• Working knowledge of Microsoft Office software and other basic computer applications.
  
  
• Proficiency using handheld technology, such as smartphones and iPads, and network-based systems.
  
  

• Knowledge of general safety and hygiene practices.
  
  
• Ability to follow and understand written procedures and protocols.
  
  
• Excellent attention to detail and ability to complete accurate documentation.
  
  
• Ability to work in a fast-paced, team-oriented environment while maintaining a high level of quality and safety.
  
  
• Strong analytical and problem-solving skills.
  
  
• Strong written and verbal communication skills.
  
  
• Manufacturing experience in the pharmaceutical or medical device industry.
  
  
• Experience in a clean room and aseptic manufacturing environment.
  
  
• Experience with liquid injectable aseptic filling and finishing.
  
  
• Mechanical aptitude and troubleshooting ability.
  
  
• BioWork Aseptic Certification.