Manufacturing Technician , MD Fill, A1 Shift - WACO, TX

Manufacturing Technician I, MD Fill, A1 Shift

This is a MD Fill - Aseptic Gown - A1 Shift: 6am-6:30pm Sunday/Monday/Tuesday & 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.