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Job Description

About the role:

The role 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. He/She is expected to fully participate in both departmental projects and any quality working teams which may be applicable.  He/She initiates new documents for procedures which are simple in nature and may also make minor revisions to existing documents.  The incumbent can troubleshoot simple existing procedures. He/She may demonstrate procedures as a part of a training session and may schedule department or process activities which could involve coworkers.

How you will contribute:

• Prepare media and buffer solutions.

• Operate Clean-in-Place (CIP) and Steam-in-Place systems. Assemble and operate filtration systems.

• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).

• Monitor and record critical process parameters.

• Complete all relevant paperwork following GDP/GMP guidelines.

• Perform routine maintenance and cleaning of production 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 1+ years of related experience or associate degree or higher with no prior experience required.

• Knowledge of cGMP manufacturing.

• Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.

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

• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.

• 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.

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.

• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).

• Must be able to stand for extended periods of time over an entire 8 or 12-hour shift. Must be able to climb ladders and stairs while wearing special gowning.

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

• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

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

• Will work in a cold, wet environment.

• Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.

• May be required to work in a confined area.

• Some Clean Room and cool/hot storage conditions.

• May require immunization before performing work within the manufacturing area.

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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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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Job Exempt