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Job Description

About the Role:

As a Manufacturing Technician II, you will execute all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, this role may 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 role has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

How you will contribute:

• Operate Clean-in-Place (CIP) and Steam-in-Place systems.
• Assemble valve assemblies and filter carts
• Operate general production equipment (such as autoclave, COP washer, etc.)
• Execute Electronic Batch Management (EBM) program to document all activities
• Complete all relevant paperwork following GDP/GMP guidelines.
• Perform routine cleaning of production rooms and equipment to maintain in GMP fashion.
• Perform sampling using aseptic techniques
• Participate on Continuous Improvement Teams
• Receive and distribute supplies into production areas as necessary.
• Train and mentor other team members
• Revise and review pertinent documentation as appropriate
• Assist in troubleshooting process problems and responding to alarms
• May perform other duties as assigned

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 basic chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word and Excel.
• Good interpersonal skills and be able to work effectively and efficiently in a team environment.
• This position requires shift, weekend and holiday work. Overtime may be required at times.
• The incumbent must work in a clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
• 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. You may:

• 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/or 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.
• Must be able to lift 25-50 lbs.
• Continuous standing for 10 -12 hours.
• Frequently or constantly lift, carry push, pull, or move objects and repetitive motions.
• Must be able to work multiple shifts, including weekends.
• Maybe required to work in a confined area.
• Some clean room and cool/hot storage conditions.
• Subject to inside environmental conditions.
• Must be able to work off hours as required.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to