Aseptic Filling Technician I/II - 2nd Shift

Aseptic Filling Technician I/II - 2nd Shift

Location: NC-Clayton, US

Shift: 2nd

Hours: 3pm-11:30pm

Tech I:

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

Tech II:

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 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 their acceptable aseptic gowning qualification and media fill certification

Knowledge, skills & abilities:

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.

Requirements:

One year of pharmaceutical, chemical and/or production manufacturing experience in a regulated industry (FDA, USDA, NRC) obtained within the last 5 years OR

Graduation from an accredited college/university with an Associate's or Bachelor's degree in: Biology, Chemistry, Biochemistry, Engineering, Pharmaceutical Technology, Business, Teaching or a related curriculum OR

Completion of the Bioworks Certification Program

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.