Aseptic Fill Technician II - Biologics Processing

Jobtailor; Clayton (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

Jobtailor is seeking qualified technicians to operate in a biologics processing environment supporting plasma-derived pharmaceuticals. Responsibilities include setting up and maintaining equipment, cleaning and sanitizing, operating sterilization and inspection systems, and meticulously documenting production activity.

Requirements include a High School Diploma, Bioworks Certification preferred, strong math/mechanical aptitude, aseptic capabilities, and the ability to lift up to 50 pounds.

Qualifications

• High School Diploma
• Bioworks Certification preferred
• Good math and mechanical aptitude
• Ability to perform skills 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
• Continuous standing, walking and some bending required
• Off-shift and overtime work may be necessary
• Accurate documentation skills
• Basic computer skills
• Mechanical aptitude
• Ability to work independently and use good judgment
• Ability to handle multiple priorities
• Maintain acceptable aseptic gowning qualification and media fill certification
• Hearing acuity essential
• Color perception/discrimination; far vision correctable in one eye to 20/30 and to 20/100 in the other eye
• Ability to communicate and understand information presented through spoken and written words and sentences
• Ability to perform simple and routine tasks by following written or oral instructions/procedures

Responsibilities

• Set up and operate equipment in a biologics processing environment for plasma-derived pharmaceuticals
• Clean, sanitize, disassemble and reassemble production equipment and fill suites
• Operate glass inspection stations, rinser/tunnel, VAM, over sealer, final-container lyophilization, heat treatment, pasteurization and cold box equipment as applicable
• Load carts with vials or syringes
• Perform SIP/PBC operations and filter integrity testing
• Prepare and label chemical solutions and materials according to BPRs and non-routine requests
• Perform material handling and glass inspection activities
• Operate motorized transport equipment such as forklifts and lift jacks
• Operate filter integrity testers and gas chromatography for Lexsol detection
• Monitor SCADA, Andover and other computer control systems
• Perform real-time production documentation and maintain accurate records and logs
• Demonstrate aseptic techniques and maintain gowning and media-fill qualifications
• Recognize safety hazards and use troubleshooting skills to provide solutions
• Train less experienced technicians in applicable computer systems
• Maintain housekeeping and keep production areas neat and free from clutter

Skills

Equipment Operation

Production Documentation

Material Handling

Glass Inspection

Chemical Preparation

SIP/PBC Operations

Lyophilization

Heat Treatment

Gas Chromatography

Forklift Operation

Education

High School Diploma

Bioworks Certification

Media Fill Certification

Tools

SCADA Systems

Andover Control Systems

Filter Integrity Testers

Motorized Transport Equipment

Job description

Jobtailor is seeking qualified technicians to operate in a biologics processing environment supporting plasma-derived pharmaceuticals. Responsibilities include setting up and maintaining equipment, cleaning and sanitizing, operating sterilization and inspection systems, and meticulously documenting production activity.

Requirements include a High School Diploma, Bioworks Certification preferred, strong math/mechanical aptitude, aseptic capabilities, and the ability to lift up to 50 pounds.