Aseptic Filling Technician 2nd Shift

Grifols, S.A; Clayton (NC); On-site; USD 42,000 - 64,000; Full time

Job summary

Grifols is seeking an Aseptic Filling Technician II for the 2nd shift (3:00PM–11:30PM, Monday–Friday) in Clayton, NC. The role involves setting up and operating fill equipment in a biologics processing environment, maintaining aseptic conditions, and supporting cleaning and documentation per BPR standards.

The technician will handle related equipment (rinser/tunnel, VAM, final container processes), monitor SCADA/Andover systems, and assist with training while upholding strict safety and aseptic

Qualifications

• One year of regulated industry experience (FDA/USDA/NRC) or college degree
• Bioworks Certification Program completed (preferred)
• Strong math and mechanical aptitude for aseptic tasks
• Able to lift up to 50 lbs and stand for long periods
• Ability to work overtime and off-shifts

Responsibilities

• Set up and operate equipment in a biologics processing environment
• Operate fill equipment and related support equipment (rinser/tunnel, VAM, etc.)
• Perform SIP/PBC operations and filter integrity testing
• Prepare chemical solutions and maintain aseptic conditions
• Document BPR records and monitor SCADA/Andover control systems
• Assist with training and maintain aseptic gowning qualifications
• Cleanroom housekeeping and sanitation per procedures
• Handle materials and inspect glass and vials

Skills

Math aptitude

Mechanical aptitude

Teamwork

Aseptic environment

Physical endurance

Education

Associate's or Bachelor's degree

Bioworks Certification Program

Tools

SCADA

Andover

Job description

Shift

2nd

Hours

03:00PM - 11:30PM Monday-Friday

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 solutions for production use; strictly adhere to department safety rules
• Perform material handling and glass inspection activities
• Conduct detailed facility housekeeping (minor cleaning, keeping work and production area neat and free from clutter, etc.)
• Carry out cleaning and sanitization per procedures, including documentation, mopping, and disinfecting floors, walls, and equipment
• Document real‑time BPR during production runs and maintain accurate records/logs
• Monitor and operate computer control systems for production activities (SCADA and Andover)
• Perform all duties described at the Technician level
• Fill room qualified to set up and operate fill equipment independently in an aseptic environment; demonstrate department‑specific aseptic techniques and capabilities; may operate and monitor final container lyophilization, heat treatment, pasteurization, and cold box
• Operate filter‐integrity tester
• Prepare and properly label samples per BPR and non‑routine requests; independently interpret and use information from company support systems
• Assist with training responsibilities for the Technician level; train less experienced Technicians in applicable computer systems
• Maintain acceptable aseptic gowning qualification and media fill certification

Knowledge, Skills & Abilities

Must possess strong math and mechanical aptitude to perform tasks in an aseptic environment. Production experience in a high‑volume manufacturing setting is desired. Must be able to maintain product sterility, work efficiently as a team member, lift up to 50 lbs, stand, walk, and bend continuously; off‑shift and overtime work may be required.

Requirements

• One year of regulated industry (FDA, USDA, NRC) experience OR graduation from an accredited college/university with an associate’s or bachelor’s degree OR completion of the Bioworks Certification Program (preferred)

Tech II: In addition to the requirements listed above, an Aseptic Filling Technician II typically requires one year of experience as an Aseptic Filling Technician.

Physical Demands / Work Conditions

Work performed in a manufacturing environment with rotating shifts; exposure to biological fluids with potential infectious organisms; exposure to chemicals, electrical equipment, moving machinery, and high noise levels; occasional entry into confined spaces requiring kneeling and squatting. Personal protective equipment required: protective eyewear, chemical suits, safety shoes and/or rubber footwear, gloves, hearing protection, respirator. Work involves sitting for 4‑6 hours per day, walking, standing, and bending waist for 2‑4 hours; frequent hand movements with one hand capable of making fast, simple motions; precise finger coordination for grasping and manipulating objects; light to moderate lifting and carrying of 15‑44 lbs for 1‑2 hours per day with a maximum lift of 50 lbs; may reach above and below shoulder height. Hearing acuity essential. Color perception/discrimination and visual acuity: 20/30 in one eye and 20/100 in the other (correctable). Ability to communicate information and ideas clearly, and to listen and understand information presented verbally and in writing.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. All qualified applicants will be considered in accordance with applicable laws.