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Job Description

About the role:

The Lead Manufacturing Technician is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. You will fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. In addition to making routine revisions to documents, you will rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. The position requires technical and administrative competence to organize and lead production activities, including demonstrating leadership in cGMP compliance, and environmental health and safety skills.

How you will contribute:

• Lead training efforts and mentoring for manufacturing tech progression from level 1-3.

• Conduct safety Gemba’s and provide coaching daily to ensure technicians are adhering to proper ergonomic techniques.

• Support all local manufacturing operations.

• Demonstrate proficiency in electronic systems such as (EBM, JDE, etc.)

• Operate general production equipment (such as Filling, Inspection & Packaging equipment).

• Ensure relevant paperwork following GDP/GMP guidelines.

• Manually clean all portable equipment and small parts.

• Participate on Continuous Improvement Teams.

• Receive and distribute supplies into the production area as necessary.

• Monitor daily cleaning of the production area to maintain in GMP fashion.

• Assemble and operate filtration systems.

• Ensure all components necessary for Manufacturing are prepped and ready to meet schedule adherence in addition to setting up incoming shift for success.

• Troubleshoot process & equipment problems in a timely manner to minimize Manufacturing downtime.

• Coordinate with other groups such as maintenance/metrology to ensure preventative maintenance is done per plan.

• May perform other duties as assigned.

• Must be able to speak, read, write, and follow detailed written and oral instructions in English.

• Must have excellent written and verbal communication skills and understanding of cGMP regulations. 

• Exceptional procedural writing skills, required.

• Skilled with pharmaceutical production equipment including but not limited to autoclave.

• Must be able to apply quantitative analysis to analyze process performance.

• Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.  

• Highly effective interpersonal skills and be able to work effectively and efficiently in a team environment.

• Knowledgeable of chemical and biological safety procedures.

• Good computer skills.

What you bring to Takeda:

• High school diploma or GED.  6+ years of experience or AA or higher with 4+ years related work experience.

Important Considerations

At Takeda, our patients rely on us to