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Job Description

Job Title: Manufacturing Associate

Location: Thousand Oaks, CA

About the role:

As a Manufacturing Associate, you will perform all processes in the production area while strictly observing CGMP, environmental health and safety guidelines and any other related regulations. You will report to the Manufacturing Supervisor.

You will work from 6:00 PM - 4:30 AM on a rotating 10-hour shift, Monday through Thursday.

How you will contribute:

• Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations.
• Execute processes in production while strictly observing cGMP, environmental health and safety guidelines and any other related regulations which could apply.
• Clean, operate, and teardown of equipment such as tanks, filtration systems, filling lines, lyophilizers, etc.
• Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.
• Receive and distribute supplies into the manufacturing areas.
• Set up operations, daily maintenance, and breakdown of simple/routine equipment.
• Gain qualification to perform CIP, SIP autoclave, small parts preparation.
• Identify processing gaps and assist with implementation of new technologies.
• Perform minor to moderate troubleshooting.
• Draft simple to moderate DCRs and complete minor NCR investigations.
• May perform other duties as assigned.
• Enthusiastic team player with demonstrated history of flexibility..
• Able to work effectively and efficiently in a team environment.
• General knowledge with cGMP manufacturing, regulatory regulations and requirements would be ideal.

What you bring to Takeda:

• High school diploma or equivalent required; bachelor's degree preferred.
• No minimum years of experience required; 1-2 years preferred.

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:

• The overall physical exertion of this position requires medium to heavy work.
• May be required to gown frequently and balance when gowning into clean areas.
• May require the use of special visual or auditory protective equipment.
• May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
• May work and have exposure to hot, cold, wet environment/conditions.
• May be required to work in confined areas; may be required to work around moving equipment and machinery.
• May be required to work at heights above floor level.
• May be required to sit between 1-2 hours.
• May be required to climb (use step stools and ladders) or kneel up to 1 hour.
• Requires repetitive use of both right and left hands and arms up to 3-4 hours.
• May be required to walk, stand, or bend at the neck/waist for over 4 hours
• May be required to squat between 1-2 hours.
• May be required to reach above/below the shoulder between 3-4 hours.
• May be required to twist at the waist up/twist at the neck up to 1 hour.
• May be required to lift up to 50lbs; Lifts per shift are up to 100 times.
• May be required to carry up to 50lbs; Carry distance of up to 6 feet; Carries per shift are up to 100 times.
• May require simple grasping & pushing/pulling with hands/arms between 3-4 hours; power gra