Manufacturing Technician I, MD Fill - B2 Shift

AbbVie • Waco, TX

1d

About The Position

Performs functions associated with current good manufacturing practice (cGMP) manufacturing operations in a biologics production facility. The role includes working with engineers on setup and calibration tasks, performing rework and quality testing related to production parts, components, and final materials, and using systems such as LIMS, SAP, and automated control systems to collect and evaluate operating data. That 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 from 6:00 p.m. to 6:30 a.m. Wednesday through Friday and every other Saturday. The position requires working in a clean room, wearing a full-body aseptic gown during an 8-hour shift, following gowning, PPE, hygiene, sanitation, environmental monitoring, and documentation procedures, and completing manufacturing activities including material handling, sampling, preparation, and processing.

Requirements

• Ability to become aseptic gown certified.
• High school diploma or equivalent experience with 2 or more years of experience; alternatively, an associate degree in science with 1 or more years of relevant experience; or a bachelor's degree with 0 or more years of relevant experience.
• Ability to recognize when accepted practices are deviated from.
• Good handwriting is a plus.
• Willingness to complete lot cleaning and sanitation during the work shift.

Nice To Haves

• Aseptic experience.
• Aseptic PPE experience.

Responsibilities

• Ship finished materials and maintain inventory levels.
• Sample in-process and raw materials.
• Operate the 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.
• Follow clean room entry and exit procedures and wear required aseptic gowning and PPE correctly.
• Perform hand hygiene and sanitization before entering the clean room, and maintain aseptic technique to prevent contamination.
• Sanitize work surfaces, tools, and equipment frequently and consistently.
• Minimize movement, talking, and unnecessary activity in the clean room.
• Inspect gowning and PPE for proper fit and integrity before use.
• Immediately report contamination concerns, spills, or equipment issues.
• Handle sterile materials only in approved areas and in a controlled manner.
• Follow environmental monitoring and cleaning requirements.
• Dispose of waste and contaminated materials according to procedure.
• Complete required documentation accurately and on time.
• Complete lot cleaning and sanitation during the work shift.
• Perform cGMP manufacturing operations, including setup and calibration work with engineers, rework, and quality testing.
• Use LIMS, SAP, automated control systems, and similar programs to collect and evaluate operating data, and make on-line adjustments as appropriate.
• Determine and potentially assist in developing methods and procedures to control or modify manufacturing processes.

Benefits

• Paid time off, including vacation, holidays, and sick leave.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• 401(k).
• Eligibility to participate in short-term incentive programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED