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Job Description

About the role:

As the Manufacturing Tech I, you will implement all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. You will participate in both departmental projects and any quality working teams. You will initiate new documents for procedures which are simple in nature and may also make minor revisions to existing documents. You will troubleshoot simple existing procedures. You will demonstrate procedures as a part of a training session and may schedule department or process activities which could involve coworkers. You will report to Supervisor, Manufacturing.

The hours of this position are 6PM-6:30AM on a 2-2-3 schedule.

How you will contribute:

• Knowledge of cGMP manufacturing.
• Knowledge of basic laboratory and pharmaceutical production equipment including: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
• You must be proficient in multiple mathematical disciplines and be able to work with both the metric and USA standards of measurement.
• Knowledge of basic chemical and biological safety procedures.
• Knowledge of Microsoft Word and Excel.
• Prepare media and buffer solutions.
• Operate Clean-in-Place (CIP) and Steam-in-Place systems. Assemble and operate filtration systems.
• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers).
• Monitor and record critical process parameters.
• Complete all relevant paperwork following GDP/GMP guidelines.
• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
• Perform sampling using aseptic techniques.
• Participate on Continuous Improvement Teams.
• Receive and distribute supplies into production areas.
• Mentor other team members.
• Revise and review important documentation.
• Help troubleshooting process problems and responding to alarms.

What you bring to Takeda:

• Requires high school diploma or GED plus 1+ years of related experience or associate degree or higher with no prior experience required.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Will wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Some Clean Room and cool/hot storage conditions.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Will require bending, twisting, reaching overhead, and squatting motions to perform certain tasks.
• Will carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• Will stand for extended periods of time over an entire 8 or 12-hour shift.
• Will climb ladders and stairs while wearing special gowning..
• Will work overtime.
• May work in a confined area.

More about us:

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