Position Summary
The Sterile Production Technician is responsible for the aseptic filling of bacteriostatic water into 30 mL sterile vials using calibrated micro piston pumps while operating within an ISO 5 laminar airflow hood. The technician performs rubber stoppering and aluminum crimp sealing of filled vials while maintaining strict aseptic technique and compliance with current Good Manufacturing Practices (cGMP), facility SOPs, and applicable quality standards. This position is scheduled for second shift, Monday through Friday, from 5:00pm - 1:00am.
Essential Duties and Responsibilities
Jobs and responsibilities are not limited to…
- Assemble sterile components and production equipment.
- Perform line clearance before beginning operations.
- Ensure all required equipment has current calibration status.
- Disinfect all materials entering the ISO 5 work area according to SOPs.
- Maintain ISO 5 aseptic conditions throughout production.
Filling Operations
- Operate calibrated micro piston pumps for sterile filling operations.
- Accurately dispense the specified volume of bacteriostatic water into sterile 30 mL Type I borosilicate glass/plastic vials.
- Continuously monitor fill accuracy during production.
- Perform in-process fill weight verification as required.
- Monitor pump performance and report abnormalities immediately.
- Minimize interruptions to laminar airflow.
Rubber Stoppering
- Aseptically place sterile rubber stoppers into filled vials.
- Ensure proper stopper placement without compromising sterility.
- Inspect vials for damaged or improperly seated stoppers.
- Remove defective units from production.
Crimping Operations
- Operate vial crimping equipment according to validated procedures.
- Apply sterile aluminum seals to achieve consistent container closure integrity.
- Verify proper crimp quality throughout production.
- Perform routine crimp inspections
Equipment Care
- Perform equipment setup and basic operational checks.
- Clean production equipment according to SOPs.
- Assist with routine maintenance activities.
- Report equipment malfunctions promptly.
Cleanroom Compliance
- Follow approved gowning procedures.
- Maintain aseptic technique at all times.
- Adhere to cleanroom behavior requirements.
- Participate in environmental monitoring activities as required.
- Perform cleaning and sanitization according to facility procedures
Pay: $19.00 - $22.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
