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.
This position includes significant duties such as:
• 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.
Experience: 3 - 12 months’ experience
Desired experience: Manufacturing experience and/or working in clean room environment
Education: High School Diploma or GED required.
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