Grifols
Aseptic Filling Technician I/II - Weekend Day
Grifols, Clayton, North Carolina, United States, 27520
Aseptic Filling Technician I/II - Weekend Day
Location: NC-Clayton, US Contract Type: Regular Full-Time Area: Manufacturing SHIFT: WEEKENDS - 12 Hr Days HOURS: 7:00 AM- 7:00 PM and every other Monday 7am-3pm 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.
Location: NC-Clayton, US Contract Type: Regular Full-Time Area: Manufacturing SHIFT: WEEKENDS - 12 Hr Days HOURS: 7:00 AM- 7:00 PM and every other Monday 7am-3pm 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.