Aseptic Filling Technician I/II (3rd Shift)

GRIFOLS, S.A.•NC-Clayton, CA

1d•Onsite

About The Position

The Aseptic Filling Technician I/II role performs production and facility-support activities in a GMP environment for plasma-derived pharmaceuticals. Technician I is an entry-level role focused on cleaning and maintaining the workplace, disassembling, cleaning, and reassembling production equipment, assisting with process-control manipulations, operating computer control systems and analytical equipment, and completing accurate real-time production documentation. Technician II performs these tasks independently and is also expected to identify safety hazards, troubleshoot within the scope of the role, and provide basic training to less experienced personnel. The position operates on the third shift, 11:00 p.m. to 7:30 a.m., Monday through Friday. Work takes place in a manufacturing environment and involves equipment setup and operation, cleaning and sanitization, material handling, aseptic gowning and techniques, and maintaining product sterility. The role may involve exposure to biological fluids, chemicals, electrical equipment, moving machinery, and high noise levels, as well as occasional entry into confined spaces. Personal protective equipment is required.

Requirements

High school diploma.
Good math and mechanical aptitude and ability to perform work in an aseptic environment while maintaining product sterility.
Ability to work effectively and efficiently as part of a team and to work independently using good judgment.
Ability to handle multiple priorities, be proactive and results-oriented, and demonstrate attention to detail.
Accurate documentation skills and basic computer skills.
Ability to lift up to 50 pounds.
Ability to meet the physical requirements of the role, including frequent hand movements and precise finger coordination, and occasional walking, standing, bending, reaching, and lifting or carrying.
Ability to work off shifts and overtime as necessary.
For internal candidates: 12 months as a Technician and on target for a PMP rating of “Achieves Expectations,” or 9 months as a Technician and on target for a PMP rating of “Exceeds Expectations.”
For internal Filling employees: certification to operate in the fill room and independent operation of aseptic fill-environment equipment such as the fill machine and ALUS.

Nice To Haves

Bioworks Certification.
Production work experience in a high-volume manufacturing environment.

Responsibilities

Set up and operate equipment in a biologics-processing environment for plasma-derived pharmaceuticals.
Maintain Class A/B gowning qualification for cleaning fill suites and maintain acceptable aseptic gowning qualification and media fill certification.
Operate supporting fill equipment, including glass inspection stations, rinser/tunnel, VAM, and over sealer; load carts with vials or syringes.
Perform SIP operations and filter-integrity testing.
Prepare chemical solutions for production use and follow department safety rules.
Perform material handling and glass-inspection activities.
Clean and sanitize facilities and equipment according to procedures; document sanitization, mop, and disinfect floors, walls, and equipment.
Maintain orderly work and production areas through housekeeping and minor cleaning.
Operate motorized transport equipment, such as a fork truck or lift jack, to move supplies.
Complete real-time production documentation, including BPRs, and maintain accurate records and logs.
Monitor and operate production computer-control systems, including SCADA and Andover.
Prepare and properly label materials according to BPRs and non-routine requests.
Independently interpret and use information from company support systems.
Maintain training responsibilities associated with the Technician II level.
Operate and monitor final-container lyophilization, heat treatment, pasteurization, and cold-box processes as applicable.
Operate a filter-integrity tester and gas chromatography for Lexsol detection.
Demonstrate department-specific aseptic techniques and capabilities.
Perform duties described at the Aseptic Filling Technician level.
Set up and operate equipment within an aseptic environment.
Use troubleshooting skills within job-scope responsibilities to provide solutions.
Assist with initial responsibilities for Technician-level employees and train less experienced technicians in applicable computer systems.
Recognize and identify safety hazards and provide basic training to less experienced personnel.