Fill Room Operator
$20.00 - $21.60/hour
Day and Night Shift (5:00am - 5:30pm & 5:00pm - 5:30am)
The Fill Room Operator is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Fully participate in both departmental projects and any quality working teams which may be applicable. Responsible for the hands on execution of all activities in the production area. Make routine revisions to documents, may rewrite complex procedures or initiate new procedures as applicable. Apply technical knowledge to perform complex trouble shooting tasks and may assist during the transfer of new technologies into manufacturing. Sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.
- Supports all local manufacturing operations.
- Supply components, small parts, glassware, tubing, etc. to cell culture and purification areas.
- Operate general production equipment (such as parts washers, autoclave, stir plates, etc.)
- Complete relevant paperwork following GDP/GMP guidelines.
- Manually clean all portable equipment and small parts.
- Participate on Continuous Improvement Teams.
- Receive and distribute supplies into the production area as necessary.
- Perform daily cleaning of the production area to maintain in GMP fashion.
- Prepare media and buffer solutions.
- Assemble and operate filtration systems.
- Write, revise and review pertinent documentation as appropriate.
- Train and mentor junior level technicians.
- Troubleshoot process problems and respond to process alarms.
- Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
- Initiate and/or coordinate other process improvement projects.
- May perform other duties as assigned.
- Good written and verbal communication skills and understanding of cGMP regulations.
- Familiarity with pharmaceutical production equipment including but not limited to autoclave, DP oven and CIP/SIP.
- Apply quantitative analysis to analyze process performance.
- Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Requires shift, weekend and holiday work. Overtime may be required at times.
- Work in a clean room environment wearing special garments. PPE must be worn due to safety requirements.
- Knowledge of basic chemical and biological safety procedures.
- May require immunization before performing work within the manufacturing area.
- Good computer skills
- Requires AA degree with 2-4 years experience or high school diploma with 4-6 years related manufacturing experience.