Aseptic Filling Technician 2nd 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
• Detail, 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

• Tech I/II: High School diploma OR GED required
• One year of regulated industry (FDA, USDA, NRC) experience OR Graduation from an accredited college/university with an Associate’s or Bachelor’s degree OR Completion of the Bioworks Certification Program preferred
• 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.
• Able 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.

Qualifications

• 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.