Job Description

Job Summary

Traferox Technologies is seeking an Aseptic Filling Specialist to operate filling equipment, maintain sterile conditions, and troubleshoot technical issues while ensuring accurate documentation and compliance with GMP. This role also supports validation activities, process optimization, and inventory management to enhance overall production efficiency.

Duties and Responsibilities

Operate aseptic filling equipment to ensure accurate and sterile filling of products. Perform routine cleaning and sanitization of equipment and work area to maintain a cleanroom environment. Conduct in-process checks and environmental monitoring. Troubleshoot and resolve technical issues with aseptic filling equipment. Record and maintain accurate documentation of the production process, including batch records and logbooks. Follow safety protocols to prevent contamination and ensure the safety of all personnel in the aseptic environment Assist with inventory managements / vendor relations / order placements. Perform process troubleshooting and root cause analysis specific to buffer solution manufacturing and aseptic filling, addressing deviations and ensuring continuous improvement. Participate in validation and qualification activities for manufacturing processes, equipment, and facilities, in accordance with regulatory requirements and company guidelines. Assist in developing and execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Identify opportunities for process optimization, innovation, and cost reduction. Performs all other job-related duties as assigned.

Education and Experience

Undergraduate degree in chemical process engineering, pharmaceutical Sciences, Microbiology, Biotechnology, Chemistry, Biochemistry or related field. Minimum of 2-3 years of experience in aseptic filling, sterile manufacturing, or a related role in a laboratory or pharmaceutical manufacturing. Experience with cleanroom gowning and aseptic techniques.

Skills and Knowledge

Strong interpersonal and communication skills with the ability to work independently and collaborate effectively with cross functional teams. Excellent analytical and problem-solving skills, with a keen attention to detail. Knowledge of aseptic processing, GMP, and regulatory compliance (FDA, EMA). Proficiency in statistical analysis and experimental design (e.g., Design of Experiments) is beneficial but not mandatory.

Working Conditions:

Must be able to work in a sterile, controlled cleanroom environment. Shift work and overtime may be required depending on production schedules. This role requires standing for extended periods, lifting and carrying materials up to 20 lbs. and handling sensitive equipment.
Job Type: Full-time

Pay: $55,000.00-$70,000.00 per year

Benefits:

Dental care Extended health care Vision care
Schedule:

Monday to Friday
Education:

Bachelor's Degree (required)
Experience:

process and/or equipment validation: 1 year (preferred) aseptic filling or sterile manufacturing: 2 years (required)
Work Location: In person