Manufacturing Associate I - Night Shift

Takeda • Brooklyn Park, MN

132d • $18 - $29

About The Position

As a Manufacturing Associate I, you will perform and document 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 execute validation protocols. You will report to the Manufacturing Supervisor. This is a night shift role with a rotating schedule. The working hours are from 5:45 PM to 6:15 AM.

Requirements

• High school diploma or GED.
• Experience in GMP environment preferred.
• Associates degree or higher in a scientific discipline preferred.
• Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) 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.
• Can 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 a plus.

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 as bioreactors, filtration units, chromatography systems and fixed/portable vessels.
• Perform basic troubleshooting.
• Document cGMP data for processing steps and equipment activities while following standard operating procedures.
• Execute 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.

Benefits

• Medical, dental, vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• Accrual of up to 120 hours of paid vacation for new hires

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees