Shift: 2nd shift,3pm to 12am (Mandatory overtime may be required and can occur during the work week or over the weekend.)
Duration: 3 months, possibility of extension
Job Description:
Education:
- High School Diploma or GED required.
Experience:
- 3 – 12 months of experience
The purpose of this position is:
- Performs operations to produce media products such as sterile cell culture media, salt solutions, reagents, buffers, antibiotics, therapeutics, and other sterile and non-sterile solutions.
- Performs aseptic operations, including filling and packaging finished product.
- Third shift is responsible for the facility cleaning.
- That is, getting the clean rooms ready for daily operations.
Duties:
- Performs aseptic operation inside and outside of clean room environment
- Performs clean room sterile operations; washes and sterilizes following SOPs
- Sterilizes production items by using the Autoclaves and Dry Heat Ovens
- Assists with the changeover of all manufacturing equipment as specified
- Assists with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validations as needed
- Rotates to various pre and post filling positions (prepping materials, packing, labeling, rework, bagging, etc.) as production needs are required
- Performs torque and fill checks as specified for bottle runs
- Maintains cleanliness and housekeeping for all manufacturing areas
- Attains qualification in one or more designated process and operation per current Training Matrix
- Documents all activities within batch record using current good documentation (cGMP) standards
- Assists as necessary to train new employees on manufacturing operations and tasks
- Performs basic PeopleSoft functions as required
- Contributes to continuous improvement efforts (iKaizen, Safety, Lean, etc.)
Working Conditions:
- May work in Clean Room and other regulated areas. Regularly exposed to automated equipment lines and the noise and/or vibration resulting from them.
- Stand long periods of time. Frequent lifts and moves. May lift up to 25 lbs. Wear PPE as required: gowning, safety glasses, nitrile gloves, mask, etc.
Desired experience:
- Manufacturing experience and/or working in clean room environment