Posted to MedZilla on 8/19/2019


Takeda Pharmaceuticals

US-MN, Manufacuring Associate I R0010322-MZ


 
 

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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, BEHAVIOURAL 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


Please visit our website at takedajobs.com

 
 


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