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Role Summary
Aseptic Filling Technician 1st Shift
Responsibilities
Tech I/II: 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/PBC 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
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
Tech II: Performs all duties described at the Technician level
Fill room qualified with the ability to setup and operate fill equipment independently in an aseptic environment
Demonstrates department specific aseptic techniques and capabilities
May operate and monitor final container lyophilization, heat treatment, pasteurization, and cold box
Operate filter integrity tester
Prepares and properly labels samples according to BPR and non-routine requests
Independently interprets and utilizes information from company support systems
Assist with initial training responsibilities for the Technician level
Trains less experienced Technicians in the use of applicable computer systems
Maintain aseptic gowning qualification and media fill certification
Qualifications
High School diploma OR GED required
One year of regulated industry experience OR Graduation from an accredited college/university with an Associateโs or Bachelorโs degree OR Completion of the Bioworks Certification Program preferred
Tech II: typically requires one year of experience as an Aseptic Filling Technician
Knowledge, Skills & Abilities
Good math and mechanical aptitude with ability to perform in an aseptic environment
Production work experience in a high-volume manufacturing environment is desired
Ability to function in an aseptic environment while maintaining product sterility
Ability to work effectively as a team member
Ability to lift up to 50 pounds; continuous standing, walking and some bending