Manufacturing Technician I, MD Fill - B2 Shift - WACO, TX
About The Position
The Manufacturing Technician I performs functions associated with cGMP manufacturing operations in a biologics production facility. The role includes working with engineers on setup and calibration tasks, performing rework and quality testing for production parts, components, and final materials, and using programs such as LIMS, SAP, and automated control systems to collect and evaluate operating data. This data may be used to make on-line adjustments to products, instruments, or equipment. The technician determines and may help develop methods and procedures to control or modify the manufacturing process. This is an MD Fill aseptic gowning role on the B2 night shift, scheduled 6:00 p.m.–6:30 a.m. Wednesday through Friday and every other Saturday. The technician must become aseptic-gown certified and follow clean-room procedures, aseptic practices, and documentation requirements. The work includes wearing a full-body aseptic gown during an eight-hour shift and performing sanitation and cleaning tasks.
Requirements
- Ability to become aseptic gown certified.
- Willingness to complete lot cleaning and sanitation during the work shift.
- Ability to wear a full-body aseptic gown during an eight-hour shift.
- Ability to follow clean-room procedures, aseptic practices, and PPE requirements.
- Ability to complete required documentation accurately and on time.
Nice To Haves
- Good handwriting.
Responsibilities
- Perform cGMP manufacturing operations in a biologics production facility.
- Work with engineers on equipment setup and calibration tasks.
- Perform rework and quality testing related to production parts, components, and final materials.
- Use systems such as LIMS, SAP, and automated control systems to collect and evaluate operating data and support on-line adjustments.
- Determine and potentially assist in developing methods and procedures to control or modify the manufacturing process.
- Ship finished materials and maintain inventory levels.
- Sample in-process and raw materials.
- Operate a glass washer and autoclave.
- Prepare buffers and media.
- Prepare equipment using CIP/SIP procedures.
- Perform cell culture activities from vial thaw through production scale.
- Perform column chromatography and tangential flow filtration.
- Complete lot cleaning and sanitation during the shift.
- Follow clean-room entry and exit procedures and environmental monitoring and cleaning requirements.
- Wear required aseptic gowning and PPE correctly, and inspect it for proper fit and integrity before use.
- Perform hand hygiene and sanitization before entering the clean room and maintain aseptic technique to prevent contamination.
- Frequently and consistently sanitize work surfaces, tools, and equipment.
- Minimize movement, talking, and unnecessary activity in the clean room.
- Report contamination concerns, spills, or equipment issues immediately.
- Handle sterile materials only in approved areas and in a controlled manner.
- Dispose of waste and contaminated materials according to procedure.
- Complete required documentation accurately and on time.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
