Aseptic Filling Technician – 3rd Shift

• Set up and operate equipment in a biologics processing environment for plasma-derived pharmaceuticals
• Perform Class A/B gowning and facility cleaning for fill suites
• Operate glass inspection stations, rinser/tunnel, VAM, over sealer, and other support fill equipment
• Load carts with vials or syringes
• Perform SIP/PBC operations and filter integrity testing
• Prepare chemical solutions for production use while following department safety rules
• Perform material handling and glass inspection
• Maintain facility housekeeping and sanitize floors, walls, and equipment according to procedures
• Operate motorized transport equipment such as forklifts and lift jacks
• Complete real-time production documentation, BPRs, records, and logs
• Monitor and operate SCADA, Andover, and other computer control systems
• Independently set up and operate fill equipment in an aseptic environment at Technician II level
• Operate and monitor lyophilization, heat treatment, pasteurization, and cold box processes when applicable
• Prepare and label samples according to BPRs and non-routine requests
• Interpret company support-system information
• Assist with Technician-level training and train less experienced technicians at Technician II level
• Maintain aseptic gowning qualification and media fill certification

• 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 typically requires one year of experience as an Aseptic Filling Technician
• 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 member of a team
• Ability to lift up to 50 pounds
• Ability to work rotating, off shifts and overtime as necessary
• Class A/B gowning qualification and media fill certification for applicable Technician II duties
• Ability to use computer control systems such as SCADA and Andover
• Ability to communicate and understand spoken and written information
• Ability to perform precise, coordinated finger, hand, and wrist movements
• Hearing acuity and required visual/color perception
• Ability to work around biological fluids, chemicals, electrical equipment, moving machinery, noise, and confined spaces while using required PPE

Demonstrates expertise in operating and maintaining equipment in a biologics processing environment, with a strong focus on aseptic techniques and compliance with safety regulations. Proficient in using computer control systems and performing precise operations while ensuring product sterility.

• Aseptic Filling Techniques
• SCADA Operation
• Class A/B Gowning Qualification
• Biologics Processing Experience
• Material Handling

• Aseptic Techniques
• Equipment Operation
• Glass Inspection
• SIP/PBC Operations
• Filter Integrity Testing
• Chemical Solution Preparation
• Lyophilization Processes
• Heat Treatment
• Pasteurization
• Cold Box Processes

• Team Collaboration
• Effective Communication
• Mechanical Aptitude

• Media Fill Certification
• Class A/B Gowning Qualification
• Bioworks Certification Program

• Regulated Industry
• FDA
• USDA
• NRC
• Biologics

• SCADA
• Andover
• Motorized Transport Equipment