Aseptic Filling Technician 1st Shift

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: 1st

Hours: 7am-3:30pm Monday-Friday

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).

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 set up 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 acceptable aseptic gowning qualification and media fill certification.

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.

• 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. Ability 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…