PFF - Aseptic Filling Technician I/II (3rd Shift)

Shift

SHIFT: 3rd HOURS: 11:00pm - 0730am, Monday-Friday

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.

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/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

Requirements

• High School Diploma
• Bioworks Certification preferred
• 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
• 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