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Manufacturing Associate I

Brooklyn Park, Minnesota

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

  • Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Here, you will feel welcomed, respected, and valued as a vital contributor our global team.

  • Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

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Manufacturing Associate I

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Job ID R0021098 Date posted 07/31/2020 Location Brooklyn Park, Minnesota

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Job Description

OBJECTIVES:

  • Perform and document daily manufacturing operations according to SOP’s in a cGMP environment
  • Operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels)
  • Execute validation protocols
  • Create or revise cGMP documents

ACCOUNTABILITIES:

  • With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels.
  • Perform basic trouble shooting
  • Performs/assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems
  • Documents cGMP data and information for processing steps and/or equipment activities while following standard operating procedures.  Key documentation includes batch records, work orders, and equipment logbooks.
  • Executes batch records and validation protocols under supervision/direction of others
  • Author and review equipment use logs
  • Performs inventory transactions in SAP
  • Performs data entry into LIMS
  • Accountable for completing assigned trainings within required timeline and actively participate in training activities.
  • Stock production and cleaning supplies
  • Perform cleaning/sanitizing production rooms and equipment
  • Other duties as assigned

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Preferred combination of education and experience:

  • Bachelor’s degree in Science or Engineering; or
  • Associate’s degree in science-related area and 1 or more years of relevant experience; or
  • High school diploma or GED and 3 or more years of relevant experience.
  • Experience in a regulated environment preferred

Knowledge, competencies and skills:

  • Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred
  • Familiar or experience with cGMP within Biotech or Pharmaceutical operations preferred
  • Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus
  • Prior experience with lab equipment a plus
  • Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
  • Must have excellent written and oral communication skills
  • Must be team and detail-oriented and able to work in a fast-paced environment.
  • Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)
  • Must be able to read and understand English

LICENSES/CERTIFICATIONS:

  • N/A

PHYSICAL DEMANDS:

  • 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

OTHER REQUIREMENTS:

  • 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

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0021098

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