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, etc.
Cleaning - Sanitization per procedures, documentation of sanitization, mopping, disinfecting (floors, walls, equipment)
Operate motorized (ie Fork truck, lift jack, etc.) transport equipment for moving supplies
Real time documentation (i.e. BPR) during production run and maintain accurate records/logs
Monitor and operate various computer control systems for production activities i.e. SCADA and Andover
Responsibilities:
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 capabilitiesMay 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 requestsIndependently 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 their acceptable aseptic gowning qualification and media fill certification
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 work effectively and efficiently as a member of a team. Able to lift up to 50 pounds. Continuous standing, walking and some bending is required. Off shift and overtime work may be necessary.
Tech II: In addition to the requirements listed above, the Aseptic Filling Technician II typically requires one year of experience as an Aseptic Filling Technician.
Work is performed in a manufacturing environment with rotating shifts. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to chemicals and to electrical manufacturing equipment and moving machinery. Exposure to high levels of noise. Occasional entry into confined spaces, requiring kneeling and squatting. Personal protective equipment required such as; protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection and a respirator. Work is performed sitting for 4-6 hours per day. Occasionally walks, stands and bends waist for 2-4 hours per day. Frequent hand movement of one hand with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Light to moderate lifting and carrying of 15-44lbs. for 1-2 hours per day with a maximum lift of 50lbs. May reach above and below shoulder height. Hearing acuity essential. Color perception/discrimination, far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures.
