Aseptic Technician – I

Job Description

Job Summary:

• The main function of an Aseptic Technician is to support the manufacturing of sterile pharmaceutical products by performing tasks in controlled environments using aseptic techniques.
• A typical Aseptic Technician ensures product integrity and compliance with regulatory standards through meticulous attention to cleanliness, documentation, and process control.

Duties and Responsibilities:

• Perform aseptic gowning and operate in cleanroom environments.
• Prepare, sterilize, and transfer materials and equipment into cleanrooms.
• Execute aseptic filling, compounding, and packaging processes.
• Monitor environmental conditions and report deviations or contamination risks.
• Follow Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).
• Maintain accurate batch records and documentation.
• Participate in cleaning, sanitization, and routine maintenance of cleanroom areas.
• Support quality assurance and validation activities.

Education/Experience:

• High school diploma or GED required.
• Associate degree or technical training in life sciences preferred 0-2 years of experience in aseptic processing, pharmaceutical manufacturing, or a related field.

Knowledge, Skills and Abilities:

• Knowledge of aseptic techniques and cleanroom protocols.
• Strong attention to detail and adherence to procedures.
• Ability to work in a sterile, regulated environment for extended periods.
• Familiarity with GMP, FDA, and other regulatory requirements.
• Good communication and teamwork skills.
• Basic computer and documentation skills.