Posted to MedZilla on 11/14/2019

Takeda Pharmaceuticals

US-MN, Manufacture Associate II R0013041-MZ


By clicking the Apply button, I understand that my employment application process with Takeda will commence and that I agree with Takeda s Privacy Notice, Privacy Policy and Terms of Use.

Job Description


  • Performs and documents 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/revise cGMP documents
  • May be responsible for training less experienced or new manufacturing associates


  • With general supervision or guidance will assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels
  • Performs basic trouble shooting and root cause analysis. May participate in resolving issues regarding operations
  • 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 relatively independently after training and instruction
  • Author and Review Equipment Use Logs
  • Performs inventory transactions in SAP
  • Performs data entry into LIMS
  • Utilizes manufacturing knowledge to train others and improve process operations
  • Monitor moderate to complex processes and identify if there is a deviation
  • Author and/or Review SOP and Batch Record revision
  • 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


Preferred combination of education and experience:

  • Bachelor s degree in Science or Engineering and 2 or more years of experience in a GMP environment; or
  • Associate degree and 3 or more years of experience in a GMP environment; or
  • High school diploma or GED and 5 or more years of experience in a GMP environment.

Knowledge, competencies and skills:

  • Practical application and knowledge of current Good Manufacturing Practices (cGMP s) and Good Documentation Practice (GDP)
  • Experience with cGMP within Biotech or Pharmaceutical operations preferred.
  • Prior experience with lab equipment, computers, and intermediate mathematical skills
  • Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management
  • Strong mechanical ability/expertise; including understanding equipment function and application
  • Proficient and knowledgeable in the operation and basic troubleshooting of at least one manufacturing area preferred (i.e. downstream, upstream and/or media buffer)
  • Ability to train less experienced or new manufacturing associates.
  • Must be team and detail-oriented and able to work in a fast-paced environment
  • Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding
  • Possess excellent written and oral communication skills.
  • 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


  • 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


  • 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


Brooklyn Park, MN

Worker Type


Worker Sub-Type


Time Type

Full time

Please visit our website at


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.