Aseptic Filling Technician I 1st Shift

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, developing, producing, and marketing innovative medicines, solutions, and services in more than 110 countries and regions.

Schedule

1st shift, 7am–3:30pm Monday–Friday

Responsibilities

• Tech I/II:
  • 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 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
  • Strict adherence to department safety rules
  • Perform material handling and glass inspection activities
  • General facility housekeeping: minor cleaning, keeping work and production areas neat and free from clutter
  • Cleaning and sanitization per procedures, documentation of sanitization, mopping, disinfecting (floors, walls, equipment)
  • Operate motorized transport equipment (e.g., forklift, lift jack) for moving supplies
  • Real-time documentation (e.g., BPR) during production runs and maintain accurate records/logs
  • Monitor and operate various computer control systems for production activities (e.g., SCADA and Andover)
• Tech II only:
  • Perform all duties described at the Technician I level
  • Fill-room qualified with the ability to set up and operate fill equipment independently in an aseptic environment
  • Demonstrate department-specific aseptic techniques and capabilities
  • Operate and monitor final container lyophilization, heat treatment, pasteurization, and cold box
  • Operate filter integrity tester
  • Prepare and properly label samples according to BPR and non-routine requests
  • Independently interpret and utilize information from company support systems
  • Assist with initial training responsibilities for Technician I level
  • Train less experienced Technicians in the use of applicable computer systems
  • Maintain acceptable aseptic gowning qualification and media fill certification

Requirements

• High School diploma or GED required
• 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 above, typically requires one year of experience as an Aseptic Filling Technician

Skills

• Good math and mechanical aptitude with the ability to perform skills in an aseptic environment
• Production work experience in a high-volume manufacturing environment (desired)
• Able to function in an aseptic environment while maintaining product sterility
• Able to work effectively and efficiently as a team member
• Able to lift up to 50 pounds
• Continuous standing, walking, and some bending required
• Off-shift and overtime work may be necessary
• Work is performed in a manufacturing environment with exposure to:
  • Biological fluids with potential exposure to infectious organisms
  • Chemicals and electrical manufacturing equipment
  • Moving machinery
  • High levels of noise
  • Confined spaces requiring kneeling and squatting
• Personal protective equipment required, such as:
  • Protective eyewear
  • Chemical suits
  • Safety shoes and/or rubber footwear
  • Gloves
  • Hearing protection
  • Respirator
• Work is performed sitting for 4–6 hours per day; occasionally walks, stands, and bends waist for 2–4 hours per day
• Frequent hand movement with the ability to make fast, simple movements of the fingers, hands, and wrists
• Ability to make precise coordinated movements to grasp and manipulate objects
• Light to moderate lifting and carrying of 15–44 lbs. for 1–2 hours per day (maximum lift of 50 lbs.)
• May reach above and below shoulder height
• Hearing acuity essential
• Color perception/discrimination, far vision correctable in one eye to 20/30 and to 20/100 in the other eye
• Able to communicate information and ideas so others will understand; ability to listen to and understand information presented through spoken and written words and sentences
• Frequently performs simple and routine tasks that vary little each day by following a set of written or oral instructions/procedures

Benefits

• Employee Referral Bonus Eligible

Location: Clayton, NC (USNC0002)