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Job Description

About the role:

As a Manufacturing Technician II, You will complete all processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, you may rewrite complex procedures or initiate new procedures as applicable. You will have enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. You will have technical and administrative competence to organize and lead production activities, including demonstrating leadership in cGMP compliance, and environmental health and safety skills. You will report to Manufacturing Supervisor.

How you will contribute:

• Prepare buffer solutions.
• Operate Clean-in-Place (CIP) and Clean-out of-Place (COP) systems.
• Assemble and operate filtration systems.
• Operate general production equipment (such as pH and conductivity meters, autoclaves, refractometers).
• Monitor and record important 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.
• Write, revise, and review important documentation.
• Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.
• Initiate and coordinate other process improvement projects.
• Help troubleshoot process problems and responding to alarms.

What you bring to Takeda:

• Typically requires high school diploma or GED plus 2+ years of experience or associates' degree or higher and 1+ years of related work experience.
• Knowledge of cGMP manufacturing.
• Knowledge of basic laboratory and pharmaceutical production equipment including: process tanks, analytical equipment, and CIP/COP 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.
• Work in a team environment.
• May require immunization before performing work within the manufacturing area

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 carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• 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.
• 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 stand for extended periods of time over an entire 8 or 12 hour shift.
• Will climb ladders and stairs while wearing special gowning.
• May require bending,