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Job Description

About the role:

You will support processes in production in B5 Fractionation/Teardown (different production areas), while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the general direction of the manufacturing lead operator and the direction of the supervisor, this position shall oversee the hands-on execution of manual and automated activities in the production area and surrounding corridors outside the production area. You will always promote Takeda's focus on Patient, Trust, Reputation, and Business.

How you will contribute:

• Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.

• Support all local manufacturing operations.

• Complete relevant paperwork and electronic system prompts/tasks, following GDP/GMP guidelines.

• Working in a team environment, perform hands-on execution of manual manufacturing operations. Manual activities could include weighing and addition of chemicals, paste suspension, equipment cleaning, post-process room cleaning, small parts cleaning, equipment assembly/disassembly, transfer panel connections and other activities.

• Respond to alarms properly and accurately escalate the issue to management, and the appropriate support groups.

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

• Perform removal of hazardous waste per safety guidelines.

• Communicate issues related to safety, quality, compliance and equipment to the manufacturing lead operator and supervisor. 

• May perform other duties as assigned to enable team success and contribute toward professional development.

What you bring to Takeda:

• High school diploma or GED plus 1+ years of related experience or AA or higher with no prior experience required.

• Ability to work in a fully automated manufacturing environment utilizing various systems

• Must be able to assist with prioritization of assignments to maximize support for the manufacturing production area.

• Must have good communication skills in English (both verbal and written) and understanding of cGMP regulations in a pharmaceutical manufacturing environment.

• Must be able to read and follow detailed written procedures.

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

• Knowledge of basic chemical and biological safety procedures.

• Basic computer skills.

• Must be able to lift, push, pull and carry up to 50 lbs. with a work partner.

• Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift.

• Must be able to climb ladders and stairs while wearing special gowning.

• May require bending, twisting, reaching, and/or squatting motions to perform certain tasks.

• Must be able work in controlled environments, requiring special gowning, following gowning requirements which require crouch/bend/pull to wear protective clothing over the head, face, hands, feet & body

• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

• Will work around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection.  Facial hair must be removed if required to wear respirator.

• May work in a cold (e.g. -20C to +5C material movement/storage room), wet (e.g. production wash/cleaning areas) and loud environment (varies by production area), around blood derived products, around chemicals such as alcohol, bleach, acids, buffers and diatomaceous earth (such as Celpure, Celite or Aerosil).

• Must be able to work overtime as required, on any shift.

• May be required to work in a confined area.

• Some Clean Room and cool/hot storage conditions.

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.

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 

Takeda Compensation and Benefits Summary

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U.S. Hourly Wage Range:

EEO Statement

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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