Aseptic Filling Technician II - Weekend Day 1

GRIFOLS, S.A.•Clayton, NC

60d•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. SHIFT: WEEKENDS - 12 Hr Days Friday/Saturday/Sunday 7am-7pm & every other Monday 7am-3pm Due to the growth at the GT site and ramping up multiple Manufacturing departments, it is vital that we focus on training newer employees and maintaining existing area expertise while we work through this growth phase, no GT Manufacturing production employees are eligible to bid for this position at this time. 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 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 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

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.
Must possess a good math and mechanical aptitude with the ability to perform skills in an aseptic environment.
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.

Nice To Haves

Production work experience in a high volume manufacturing environment is desired.

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
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