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Job Description

About the role:

As a Manufacturing Associate I you will perform daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment (bioreactors filtration units chromatography systems and fixed/portable vessels) and will complete validation protocols. You will report 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.
• With general management or guidance will assemble and operate biologics production equipment such a bioreactors filtration units chromatography systems and fixed/portable vessels.
• Perform basic trouble shooting.
• Document cGMP data for processing steps and equipment activities while following standard operating procedures. Main documentation includes batch records work orders and equipment logbooks.
• With general management performs/or assists with processing steps and manufacturing support activities by managing process parameters in batch record and control systems.
• You will complete batch records and validation protocols under management/direction of others.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Perform data entry into LIMS.
• Perform cleaning/sanitizing production equipment.

What you bring to Takeda:

• High school diploma or GED.
• Experience in GMP environment would be ideal.
• Associates degree or higher in a scientific discipline would be ideal.
• Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) would be ideal.
• Knowledge of non-manufacturing functions such as QC Regulatory QA and Materials Management would be ideal.
• Prior experience with lab equipment would be ideal.
• Knowledge of mathematical calculations (addition subtraction division multiplication) and rounding.
• Can perform basic computer operations such as ability to navigate in MS Office use email and complete training using Web-based Training (WBT).
• Familiar or experience with cGMP within Biotech or Pharmaceutical operations would be ideal.

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:

• 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 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.
• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily.
• Carry weight Pushing Pulling Lifting - Required to carry lift push and 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.
• Move 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.
• Must have the ability to work assigned shift (day or night).
• Will 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.
• On rare occasions travel may be required to offsite meetings or training event.

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

Takeda Compensation and Benefits Summary

For Location:

U.S. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

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