Manufacturing Technician I, MD Fill - B2 Shift
About The Position
Performs functions associated with cGMP manufacturing operations within a biologics production facility. The role includes working with engineers on setup and calibration tasks and performing rework and quality testing related to the production of parts, components, and final materials. Uses programs such as LIMS, SAP, and automated control systems to collect and evaluate operating data, which may be used to make on-line adjustments to products, instruments, or equipment. Determines and may help develop methods and procedures to control or modify the manufacturing process. This role supports MD Fill aseptic manufacturing on the B2 night shift, scheduled 6:00 p.m.–6:30 a.m. Wednesday through Friday and every other Saturday. The technician must be able to become aseptic gown certified and wear a full-body aseptic gown during an 8-hour shift. Work takes place in a clean room and requires following aseptic gowning, hygiene, sanitation, contamination prevention, environmental monitoring, cleaning, and documentation procedures. The position works under close supervision and performs routine assignments with detailed instructions.
Requirements
- Ability to become aseptic gown certified.
- High school diploma or equivalent experience with 2+ years of experience; alternatively, an associate degree in science with 1+ years of relevant experience; or a bachelor's degree with 0+ years of relevant experience.
- Ability to recognize when accepted practices are deviated from.
- Ability to complete routine assignments under close supervision and follow detailed instructions.
- Good handwriting is a plus.
Nice To Haves
- Aseptic experience.
- Aseptic PPE experience.
Responsibilities
- Ship finished materials.
- Maintain inventory levels.
- Sample in-process and raw materials.
- Run the glass washer and autoclave.
- Prepare buffers and media.
- Prepare equipment, including CIP/SIP.
- Perform cell culture activities from vial thaw through production scale.
- Perform column chromatography.
- Perform tangential flow filtration.
- Complete lot cleaning and sanitation during the work shift.
- Follow clean-room entry and exit procedures.
- Wear required aseptic gowning and PPE correctly and consistently; inspect gowning and PPE for proper fit and integrity before use.
- 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 frequently and consistently.
- 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.
- Follow environmental monitoring and cleaning requirements.
- Dispose of waste and contaminated materials according to procedure.
- Complete required documentation accurately and on time.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
