Aseptic Filling Technician I/II (3rd Shift)

GRIFOLS, S.A.

7d•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. SFF- Aseptic Filling Technician I/II SHIFT: 3rd HOURS: 11:00PM 07:30AM Monday-Friday Summary- The Technician I is an entry level Aseptic Fill technician role that performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician I will routinely disassemble, clean, and reassemble equipment for production activities, assist with process control manipulations, use various computer control systems and analytical equipment. Perform real time documentation in appropriate production procedures while maintaining accurate records and logs. Summary- The Technician II independently performs fundamental tasks within a GMP environment by cleaning and maintaining the workplace. The Technician II will independently dissemble, clean, and reassemble equipment for production activities, perform process control manipulations, use various computer control systems and analytical equipment to perform real time documentation in appropriate production procedures while maintaining accurate records and logs. The Technician II will be expected to recognize and identify safety hazards, perform basic training to less experienced personnel, and utilize troubleshooting skills in alignment with job responsibilities.

Requirements

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.
High School Diploma. Bioworks Certification preferred.
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.

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 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
Accurate documentation skills. Basic computer skills. Mechanical aptitude. Ability to work well with others in a team environment. Self-starter with the ability to work independently and use good judgement. Able to handle multiple priorities. Proactive, results oriented, and strong attention to detail.
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.