Manufacturing Associate I

Takeda•Brooklyn Park, MN

21h•Onsite

About The Position

As a Manufacturing Associate I, you will perform daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) and will complete validation protocols. This is a day shift role with a rotating schedule. The working hours are from 5:45 AM to 6:15 PM.

Requirements

High school diploma or GED.
Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) would be ideal.
Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
Can perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web-based Training (WBT).
Must have the ability to work assigned shift (day or night).
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.

Nice To Haves

Experience in GMP environment would be ideal.
Associates degree or higher in a scientific discipline would be ideal.
Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and Materials Management would be ideal.
Prior experience with lab equipment would be ideal.
Familiar or experience with cGMP within Biotech or Pharmaceutical operations would be ideal.

Responsibilities

Perform dispensing, labeling, and transferring/staging of raw materials and parts.
Assemble/disassemble, clean, and sterilize components, parts, and equipment.
Maintain equipment, area, and cleaning logbooks.
Assemble and 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 equipment activities while following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks.
Perform/or assist with processing steps and manufacturing support activities by managing process parameters in batch record and control systems.
Complete batch records and validation protocols under management/direction of others.
Review equipment use logs with support.
Perform inventory transactions in SAP.
Perform data entry into LIMS.
Perform cleaning/sanitizing production equipment.