Manufacturing Associate - Night Shift

Overview

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.

• 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 (bioreactors, filtration units, chromatography systems and fixed/portable vessels) with general management or guidance.
• Perform basic troubleshooting.
• Document cGMP data for processing steps and equipment activities following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks.
• Assist with processing steps and manufacturing support activities by managing process parameters in batch records and control systems.
• Execute batch records and validation protocols under management/direction of others.
• Review equipment use logs with support.
• Perform inventory transactions in SAP.
• Enter data into LIMS.
• Perform cleaning/sanitizing of production equipment.

• High school diploma or GED.
• Experience in GMP environment preferred.
• Associate 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 and rounding.
• Ability to perform basic computer operations (MS Office, email) and complete training using Web Based Training (WBT).
• Familiarity or experience with cGMP within Biotech or Pharmaceutical operations a plus.

• May be required to wear personal protective equipment (PPE) and other clean room garments daily (e.g., safety shoes, safety glasses, aprons, face shields, lab coats, gowns, hair nets, gloves, hearing protection).
• Work in a cold, wet environment and around chemicals requiring respiratory protection.
• Work multiple shifts, including weekends, or be asked to work supplemental hours as necessary.
• Stand/walk for several hours daily; carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations.
• Climb stairs or ladders, bend/kneel, reach overhead, and perform repetitive movements as part of production activities.
• On rare occasions, travel may be required to offsite meetings or training events.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that aims to empower you to grow through life-changing work.

Takeda is Certified as a Global Top Employer and offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace committed to Better Health and a Brighter Future.

Locations:
Brooklyn Park, MN

Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran status, or other protected veteran status, in accordance with applicable laws.