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Job Description

Job Title: Manufacturing Associate I

Location: Brooklyn Park, MN

About the role:

As a Manufacturing Associate, you will perform and document daily manufacturing operations according to SOPs in a cGMP environment, operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels), and execute validation protocols.

This is an onsite role that reports to the Manufacturing Supervisor.

How you will contribute:

• Perform dispensing, labeling, and transferring/staging of raw materials and parts.
• Will assemble/disassemble, clean, and sterilize components, parts, and equipment. Maintain equipment, area, and cleaning logbooks.
• Assemble and operate biologics production equipment, such a bioreactors, filtration units, chromatography systems and fixed/portable vessels. Perform basic trouble shooting.
• Document cGMP data and information for processing steps and equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
• Assist with processing steps and manufacturing support activities by monitoring process parameters in batch record and control systems.
• Execute batch records and validation protocols under supervision/direction of others.
• Review equipment use logs.
• Perform inventory transactions in SAP
• Perform data entry into LIMS
• Complete mandatory training within required timeframe
• Complete other duties as assigned

What you bring to Takeda:

• High school diploma or GED required.
• Experience in GMP environment desirable.
• Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT).
• Can read and understand English.

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:

• May be required to 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/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, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must have the ability to work assigned shift (day or night).
• 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.
• On rare occasions, travel may be required to offsite meetings or training event.
• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily.
• Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materials.
• Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations.
• Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durations.
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations.
• Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time.
• Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time.
• Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time.

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 people around the world.

#GMSGQ #ZR1 #LI-MA1 #LI-Onsite

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Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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