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Job Description

Job Title: Manufacturing Associate I

Location: Brooklyn Park, MN

About the role:

You will report to the Manufacturing Supervisor

You will work night shift 5:45pm- 6:15am on a rotating schedule

• Perform and documents daily manufacturing operations according to SOPs in a cGMP environment
• Operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels)
• Build validation protocols

How you will contribute:

• Performs dispensing, labelling, 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 guidance or guidance will assemble and/or 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/or 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 overseeing process parameters in batch record and control systems.
• Accomplish batch records and validation protocols under guidance/direction of others.
• Review equipment use logs with support
• Perform inventory transactions in SAP
• Performs data entry into LIMS
• Perform cleaning/sanitizing production equipment

What you bring to Takeda:

• High school diploma or GED
• Experience in GMP environment preferred
• Associates degree or higher in a scientific discipline preferred

Key Skills, Abilities, and Competencies

• Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management
• Prior experience with lab equipment a plus
• Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding
• Ability to 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
• Can read and understand English

Other Job Requirements

Physical Demands:

• 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/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and 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 mo