Experienced Aseptic Filling Technician
About The Position
The Experienced Aseptic Filling Technician is responsible for performing sterile compounding and aseptic filling operations in accordance with current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDocP), and all applicable company procedures. This position requires prior experience in aseptic manufacturing and the ability to independently perform critical manufacturing activities while maintaining the highest standards of sterility, quality, and patient safety. The ideal candidate will possess strong technical knowledge of aseptic processing, sterile filling equipment, environmental controls, and batch documentation while working collaboratively with Manufacturing, Quality, Engineering, and Supply Chain teams to meet production schedules and compliance requirements.
Requirements
- High School Diploma or GED required.
- Minimum 3 years of experience performing aseptic filling, sterile compounding, or pharmaceutical manufacturing in a cGMP environment.
- Experience operating aseptic filling equipment and associated manufacturing systems.
- Strong understanding of: 21 CFR Parts 210 and 211, Aseptic processing principles, Good Documentation Practices (GDocP), Cleanroom behavior and contamination control, Environmental monitoring concepts
- Ability to read and interpret SOPs, batch records, specifications, and manufacturing instructions.
- Strong mathematical and mechanical aptitude.
- Excellent verbal and written communication skills.
- Ability to prioritize work while maintaining exceptional attention to detail.
- Must be able to work independently with minimal supervision.
Nice To Haves
- Associate degree in a scientific or technical discipline preferred.
- Previous experience in a 503B outsourcing facility, pharmaceutical, biotechnology, or sterile manufacturing environment strongly preferred.
- Experience with deviations, investigations, and manufacturing documentation preferred.
- Experience with media fills and aseptic process simulations.
- Experience with isolators or Restricted Access Barrier Systems (RABS).
- Experience with vial, syringe, or bottle filling operations.
- Experience participating in internal or regulatory inspections.
Responsibilities
- Perform aseptic filling operations in ISO-classified cleanrooms using approved aseptic techniques.
- Practice current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDocP) at all times.
- Prepare, assemble, sterilize, and operate aseptic filling equipment including peristaltic pumps, filling systems, tubing assemblies, and associated production equipment.
- Perform sterile compounding activities following approved batch records, SOPs, and manufacturing instructions.
- Complete production batch records accurately, legibly, and in real time.
- Perform line clearances, equipment setup, and pre-operation inspections.
- Verify materials, components, and documentation prior to manufacturing activities.
- Troubleshoot equipment and manufacturing issues while escalating concerns appropriately.
- Assist with aseptic process simulations (media fills), engineering batches, process validations, and qualification activities.
- Support equipment changeovers, cleaning, sanitization, and preventive maintenance activities.
- Maintain equipment logbooks and ensure all documentation is completed accurately.
- Perform environmental cleaning and disinfecting activities within classified manufacturing areas.
- Support environmental monitoring activities when required.
- Report deviations, non-conformances, and unusual events promptly while assisting with investigations.
- Coordinate with Quality Assurance during in-process inspections and manufacturing activities.
- Ensure manufacturing rooms remain inspection-ready at all times.
- Train and mentor less experienced manufacturing technicians on aseptic techniques and manufacturing procedures.
- Participate in continuous improvement initiatives to increase efficiency, reduce waste, and improve product quality.
- Maintain gowning qualification and comply with all gowning and contamination control requirements.
- Demonstrate safe work practices and promote a culture of quality and compliance.
- Perform additional manufacturing duties as assigned.
Benefits
- Semi-annual performance bonuses
- Comprehensive benefits package
- Paid training and career development opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
