Manufacturing Technician I, MD Fill (Aseptic Gown) B1 Shift - WACO, TX

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

Job Description

Please note this is our MD Fill (Aseptic Gown) B1 Shift:  6am-6:30pm Thursday/Friday/Saturday & every other Wednesday

Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

Responsibilities

Shipping finished materials.
Maintaining inventory levels.
Sampling of in process and raw materials.
Running glass washer / autoclave.
Buffer / media preparation.
Equipment preparation (CIP / SIP).
Cell culture (from vial thaw to production scale).
Column chromatography.
Tangential flow filtration
Wear an aseptic gown during an 8 hr shift. This gown covers the full body.
Willing to complete a lot cleaning sanitation during the work shift  
Follow all clean room entry and exit procedures
Wear the required aseptic gowning and PPE correctly at all times
Perform hand hygiene and sanitization before entering the clean room
Maintain aseptic technique to prevent contamination of materials and products
Sanitize work surfaces, tools, and equipment on a frequent and consistent basis
Minimize movement, talking, and unnecessary activity in the clean room
Inspect gowning and PPE for proper fit and integrity before use
Report any contamination concerns, spills, or equipment issues immediately
Handle sterile materials only in approved areas and in a controlled manner
Follow all environmental monitoring and cleaning requirements
Dispose of waste and contaminated materials according to procedure
Complete all required documentation accurately and on time. Good hand writing will be a huge plus.
Please note that the YouTube video is not owned, produced, or sponsored by AbbVie and does not accurately depict AbbVie’s aseptic processes and procedures. The video is provided solely as an example of the aseptic gowning process.