Experienced Aseptic Filling Technician

Job Description

Job Description

Job Title

Experienced Aseptic Filling Technician

Salary

$25.00 hourly starting based upon experience plus twice a year bonuses.

Position Summary

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.

Essential Duties and Responsibilities

Responsibilities include, but are not limited to:

• 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.

Required Education and Experience

• High School Diploma or GED required.
• Associate degree in a scientific or technical discipline preferred.
• Minimum 3 years of experience performing aseptic filling, sterile compounding, or pharmaceutical manufacturing in a cGMP environment.
• Previous experience in a 503B outsourcing facility, pharmaceutical, biotechnology, or sterile manufacturing environment strongly preferred.
• 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
• Experience with deviations, investigations, and manufacturing documentation preferred.
• 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.

Preferred Qualifications

• 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.

Competencie s

• Aseptic Technique
• Technical Troubleshooting
• Attention to Detail
• Quality Focus
• Communication
• Teamwork
• Problem Solving
• Time Management
• Continuous Improvement
• Adaptability
• Accountability

Supervisory Responsibilities

None

Work Environment

This position is performed primarily within ISO-classified cleanrooms and controlled manufacturing environments. Frequent gowning and prolonged work in sterile production suites are required.

Employees must comply with all contamination control procedures, gowning requirements, and cleanroom behaviors.

Physical Requirements

• Ability to stand for 8–10 hours.
• Ability to wear sterile gowning for extended periods.
• Ability to perform repetitive manual tasks.
• Ability to lift up to 25 pounds.
• Good visual acuity and manual dexterity.
• Ability to work while wearing gloves, masks, goggles, and other required PPE.

Schedule

Full-time Day Shift

Occasional overtime and weekend work may be required to support manufacturing schedules.

Why Join Our Team?

• Competitive compensation based on experience
• Semi-annual performance bonuses
• Comprehensive benefits package
• Paid training and career development opportunities
• Clean, modern pharmaceutical manufacturing facility
• Opportunity to work with a highly skilled team producing medications that improve patient lives
• Advancement opportunities within Manufacturing Operations

Equal Employment Opportunity

The Company is an Equal Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.