Aseptic Filling Technician 2nd Shift

Grifols•Clayton, NC

4d•Onsite

About The Position

The Aseptic Filling Technician works in a biologics manufacturing environment producing plasma-derived pharmaceuticals. The role is listed for the second shift, 3:00 p.m. to 11:30 p.m., Monday through Friday, at Grifols’ Clayton, North Carolina location. Technician II duties include all Technician-level work, plus independently setting up and operating filling equipment in an aseptic fill room, performing department-specific aseptic techniques, supporting additional processing operations, preparing samples, using company support systems, and training less-experienced technicians. Work takes place in a manufacturing environment and includes exposure to biological fluids, chemicals, electrical equipment, moving machinery, and high noise levels. The position requires maintaining aseptic gowning and media fill qualifications and may involve rotating shifts, off-shift work, and overtime.

Requirements

High school diploma or GED.
One year of regulated-industry experience in FDA-, USDA-, or NRC-regulated work, or graduation from an accredited college or university with an associate or bachelor’s degree, or completion of the Bioworks Certification Program.
For Technician II, typically one year of experience as an Aseptic Filling Technician.
Good math and mechanical aptitude, with the ability to perform skills in an aseptic environment.
Ability to work in an aseptic environment while maintaining product sterility.
Ability to work effectively and efficiently as a team member.
Ability to lift up to 50 pounds.
Ability to perform continuous standing and walking and some bending.
Ability to work off shifts and overtime when necessary.
Ability to perform precise, coordinated finger movements to grasp and manipulate objects.
Hearing acuity; color perception and discrimination; and far vision correctable in one eye to 20/30 and in the other eye to 20/100.
Ability to communicate information and ideas so others understand, and to listen to and understand spoken and written information.
Ability to perform simple, routine tasks by following written or oral instructions and procedures.
Ability to use required personal protective equipment, including protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection, and a respirator.

Nice To Haves

Production work experience in a high-volume manufacturing environment is desired.
Completion of the Bioworks Certification Program is listed as preferred.

Responsibilities

Set up and operate equipment in a biologics processing environment for plasma-derived pharmaceuticals.
Qualify for Class A/B gowning and facility cleaning of fill suites.
Operate support fill equipment, including 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 solutions for production use.
Follow department safety rules.
Perform material handling and glass inspection activities.
Maintain facility housekeeping, including minor cleaning and keeping production areas neat and free from clutter.
Clean and sanitize according to procedures, document sanitization, and mop and disinfect floors, walls, and equipment.
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 computer control systems used for production, including SCADA and Andover.
Perform all Technician-level duties as a Technician II.
Independently set up and operate fill equipment in an aseptic fill room.
Demonstrate department-specific aseptic techniques and capabilities.
May operate and monitor final-container lyophilization, heat treatment, pasteurization, and cold box operations.
Operate a filter integrity tester.
Prepare and properly label samples according to BPR and non-routine requests.
Independently interpret and use information from company support systems.
Assist with initial training of Technician-level employees and train less-experienced technicians in applicable computer systems.
Maintain acceptable aseptic gowning qualification and media fill certification.