PFF Aseptic Filling Tech I/II

GRIFOLS, S.A.•NC-Clayton, CA

8d•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: 2nd Shift HOURS: 3:00pm - 11:30pm, Monday - Friday Hiring Manager- Ben McDonald

Requirements

High School Diploma.
Internal Candidate Requirement: Requires 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" level.
In addition, required for Filling employees: Certified to operate in the fill room and able to operate aseptic fill environment equipment such as the fill machine and ALUS independently.

Nice To Haves

Bioworks Certification preferred.

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
Prepares and properly labels according to BPR and non-routine request
Independently interprets and utilizes information from company support systems
Maintaining all training responsibilities associated with the Technician II level
May operate and monitor final container lyophilization, heat treatment, pasteurization, and cold box.
Operate and filer integrity tester and gas chromatography for lexsol detection
Demonstrates department specific aseptic techniques and capabilities
Performs all duties described at the Aseptic Filling Level
Maintain acceptable aseptic gowning qualification and media fill certification.
Setup and operate equipment within an aseptic environment
Utilize troubleshooting skills in alignment with job scope responsibilities to provide solutions
Assist with initial responsibilities for the Technician level. Trains less experienced Technicians in the use of applicable computer systems.