Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MN, Manufacturing Support Technician R0011872-MZ


 
 

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Job Description

Position Title:

Manufacturing Support

OBJECTIVES:

  • Supports manufacturing department by utilizing equipment such as washers, autoclaves and material handling tools to prepare equipment and materials for the manufacturing process.
  • Performs and documents, according to SOP s, cGMP activities to support manufacturing operations. This involves operation of equipment, execution of validation protocols, and completion of cGMP documents

ACCOUNTABILITIES:

  • Performs Manufacturing Support activities such as equipment preparation and weigh and dispense of materials.
  • Documents/Records cGMP data and information for equipment activities while following standard operating procedures (SOP s). Key documentation includes validation protocols and equipment logbooks.
  • 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
  • Stock production and cleaning supplies
  • Accountable for completing assigned trainings within required timeline and actively participate in training activities
  • Performs inventory transactions in SAP
  • Other duties as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • High School Diploma or GED
  • 1-2 years relevant experience preferred.

Knowledge, competencies and skills:

  • Knowledge of current Good Manufacturing Practices (cGMP s) and Good Documentation Practices (GDP) preferred.
  • Must be team and detail-oriented and able to work in a fast-paced environment
  • Possess good written and oral communication skills.
  • Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus.
  • Basic equipment understanding, including understanding equipment function and application a plus.

LICENSES/CERTIFICATIONS:

  • N/A

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

  • Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily.
  • Carrying weight, Pushing, Pulling and 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 includes: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves. Occasionally will need to wear 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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