Aseptic Filling Technician I (1st Shift)

Role Summary

The Technician I is an entry level Aseptic Fill technician role that performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician I will routinely disassemble, clean, and reassemble equipment for production activities, assist with process control manipulations, use various computer control systems and analytical equipment. Perform real time documentation in appropriate production procedures while maintaining accurate records and logs.

Responsibilities

• Responsible for equipment setup and operation in a biologics processing environment for plasma derived pharmaceuticals
• Class A/B gowning qualified for facility cleaning of fill suites
• Operate support fill equipment such as the glass inspection stations, rinser/tunnel, VAM and over sealer. Load carts with vials or syringes
• Perform SIP Operations and filter integrity testing
• Prepare chemical solution for production use. Strict adherence to Dept. Safety Rules.
• Perform material handling and glass inspection activities
• Detailed, general facility housekeeping i.e. minor cleaning, keeping work and production area neat and free from clutter, etc.
• Cleaning - Sanitization per procedures, documentation of sanitization, mopping, disinfecting (floors, walls, equipment)
• Operate motorized transport equipment for moving supplies
• Real time documentation during production run and maintain accurate records/logs
• Monitor and operate various computer control systems for production activities

Qualifications

• High School Diploma. Bioworks Certification preferred.
• Must possess a good math and mechanical aptitude with the ability to perform skills in an aseptic environment. Production work experience in a high-volume manufacturing environment is desired. Must be able to function in an aseptic environment while maintaining the sterility of the product. Able to lift up to 50 pounds. Continuous standing, walking and some bending is required. Off shift and overtime work may be necessary.

Skills

• Operational proficiency with aseptic techniques
• Ability to work in a team environment and communicate effectively
• Mechanical aptitude and basic computer/documentation skills