Aseptic Filling Technician Jobs

The Aseptic Filling Technician plays a critical role in ensuring the safe, efficient, and precise filling of sterile pharmaceutical products into bottles, or other containers within a controlled and sterile environment. This role requires a strong understanding of aseptic techniques, equipment operation, and compliance with regulatory guidelines to maintain product quality and patient safety.

Responsibilities

The Aseptic Filling Technician plays a critical role in ensuring the safe, efficient, and precise filling of sterile pharmaceutical products into bottles, or other containers within a controlled and sterile environment. This role requires a strong understanding of aseptic techniques, equipment operation, and compliance with regulatory guidelines to maintain product quality and patient safety.

Aseptic Filling:

·Set up, operate, and maintain aseptic filling equipment, such as fillers, cappers, and sealers, ensuring accurate and consistent filling of pharmaceutical products.

·Maintain inventory, equipment and cleanroom facility

·Complete production batch records

·Conduct thorough line clearance, cleaning, and sterilization procedures before each production run to prevent cross-contamination and maintain sterility.

Quality Control and Compliance:

• Document all activities, including equipment logs, batch records, and process deviations, according to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• Assist in investigations and root cause analyses for any quality deviations, implementing corrective and preventive actions as necessary.
• Perform in-process quality checks, such as weight verification, pH; container integrity, and visual inspections, to ensure products meet specifications and regulatory standards.

Cleanroom Environment Maintenance:

• Adhere to strict aseptic techniques and gowning procedures while working within a cleanroom environment to prevent contamination.
• Perform routine environmental monitoring, including particle counts and surface swabs, to maintain controlled cleanroom conditions.

Equipment Maintenance and Troubleshooting:

• Conduct routine maintenance, calibration, and cleaning of filling equipment to ensure optimal performance and prevent breakdowns.
• Troubleshoot equipment issues and perform minor repairs, collaborating with maintenance and engineering teams for more complex problems.

Education:

·High school diploma or equivalent;

·Associate's degree or relevant technical certification preferred.

Experience:

2+ years’ experience in Aseptic filling environment.

Skills:

• Proficiency in using and troubleshooting aseptic filling equipment and related technologies.
• Excellent problem-solving and analytical skills.
• Strong understanding of GMP, SOPs, and regulatory guidelines related to aseptic processing.
• Knowledge of safety standards in a laboratory environment.
• Prior experience in aseptic filling operations within the pharmaceutical, biotechnology, or medical device industry.
• Attention to detail, excellent organizational and record keeping skills, and the ability to work effectively in a fast-paced, sterile environment.
• Strong communication skills and the ability to work collaboratively in a team-oriented setting.