Aseptic Filling Technician II – 3rd Shift

Jobtailor

Clayton (NC)

On-site

USD 52,000 - 76,000

Full time

7 days ago

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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

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

Requirements

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

Core Competencies

Demonstrates expertise in operating and maintaining equipment in a biologics processing environment, with a strong focus on aseptic techniques and accurate documentation. Proficient in performing material handling, filter integrity testing, and utilizing computer control systems to ensure product quality and safety.

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