Aseptic Filling Technician I/II (3rd Shift)

Grifols•Clayton, NC

8h•Onsite

About The Position

Grifols is hiring an Aseptic Filling Technician I/II to perform production and facility-maintenance tasks in a GMP biologics manufacturing environment for plasma-derived pharmaceuticals. Technician I is an entry-level role; Technician II independently performs core tasks, uses troubleshooting skills within the scope of the role, recognizes safety hazards, and provides basic training to less experienced personnel. Both levels clean and maintain the workplace, disassemble and reassemble production equipment, support process-control activities, use computer control and analytical systems, and document production activities in real time while maintaining accurate records. The position is based in Clayton, North Carolina. The listed schedule is third shift, 11:00 p.m.–7:30 a.m., Monday through Friday; rotating shifts and overtime may also be necessary. Work takes place in a manufacturing environment and may involve exposure to biological fluids and potentially infectious organisms, chemicals, electrical equipment, moving machinery, and high noise levels. Occasional confined-space entry may require kneeling and squatting. Required protective equipment may include protective eyewear, chemical suits, safety shoes or rubber footwear, gloves, hearing protection, and a respirator. The role involves sitting for 4–6 hours per day and occasionally walking, standing, and bending at the waist for 2–4 hours per day. It requires frequent hand and finger movements, precise coordination to grasp and manipulate objects, reaching above and below shoulder height, and lifting and carrying loads of 15–44 pounds for 1–2 hours per day, with a maximum lift of 50 pounds. Hearing acuity and specified visual abilities are essential. A high school diploma is required; Bioworks Certification is preferred. Production experience in a high-volume manufacturing environment is desired. For internal candidates, advancement requires 12 months as a Technician with a PMP rating on target for “Achieves Expectations,” or 9 months with a rating on target for “Exceeds Expectations.” Filling employees must also be certified to operate in the fill room and independently operate aseptic fill equipment such as the fill machine and ALUS.

Requirements

High school diploma.
Good math and mechanical aptitude and the ability to perform tasks in an aseptic environment while maintaining product sterility.
Ability to work effectively and efficiently as a member of a team, and independently when needed, using good judgment.
Ability to handle multiple priorities; be proactive and results-oriented; and maintain strong attention to detail.
Accurate documentation skills and basic computer skills.
Ability to lift up to 50 pounds; perform continuous standing and walking and some bending; and meet the stated physical, visual, and hearing requirements.
Ability to work off shift and overtime when necessary.
For internal candidates seeking the role: 12 months as a Technician with a PMP rating on target for “Achieves Expectations,” or 9 months as a Technician with a rating on target for “Exceeds Expectations.”
For internal Filling employees: certification to operate in the fill room and ability to independently operate aseptic fill 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, operate, clean, and maintain equipment in a biologics processing environment; disassemble and reassemble equipment for production activities.
Qualify for Class A/B gowning and clean fill suites; perform sanitization and facility housekeeping, including cleaning and disinfecting floors, walls, and equipment, and document sanitization.
Operate support fill equipment, including glass inspection stations, rinser/tunnel, VAM, and over sealer.
Load carts with vials or syringes and perform material-handling and glass-inspection activities.
Perform SIP operations and filter-integrity testing; prepare chemical solutions for production use.
Perform process-control manipulations and monitor and operate production computer-control systems, including SCADA and Andover.
Complete real-time production documentation, including BPRs, and maintain accurate records and logs.
Operate motorized transport equipment, such as a forklift or lift jack, to move supplies.
For Technician II, prepare and label items according to BPRs and non-routine requests, and independently interpret and use information from company support systems.
For Technician II, operate or monitor final-container lyophilization, heat treatment, pasteurization, and cold box as applicable; operate a filter-integrity tester and gas chromatography for Lexsol detection.
Demonstrate department-specific aseptic techniques, maintain aseptic gowning qualification and media-fill certification, and set up and operate equipment in an aseptic environment.
Recognize safety hazards and use troubleshooting skills within the scope of job responsibilities to provide solutions.
Maintain training responsibilities associated with the Technician II level and train less experienced technicians in applicable computer systems.
Follow department safety rules and work effectively as part of a team.