Manufacturing Associate - Night Shift

Overview

As a Manufacturing Associate I on the Global Manufacturing and Supply (GMS) team at Takeda, you will perform and document daily manufacturing operations in a cGMP environment, operate biologics production equipment, and execute validation protocols. This is a night shift role with a rotating schedule (5:45 PM to 6:15 AM). Reports to the Manufacturing Supervisor.

• 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.
• Operate biologics production equipment (bioreactors, filtration units, chromatography systems, and fixed/portable vessels) with general management guidance.
• Perform basic troubleshooting.
• Document cGMP data for processing steps and equipment activities (batch records, work orders, equipment logbooks).
• Assist with processing steps and manufacturing support activities by managing process parameters in batch record and control systems.
• Execute batch records and validation protocols under supervision.
• Review equipment use logs with support.
• Perform inventory transactions in SAP and data entry into LIMS.
• Perform cleaning/sanitizing of production equipment.

• High school diploma or GED.
• Experience in GMP environment preferred.
• Associates degree or higher in a scientific discipline preferred.
• Understanding of cGMP and GDP preferred.
• Knowledge of non-manufacturing functions (QC, Regulatory, QA, Materials Management) a plus.
• Prior experience with lab equipment a plus.
• Knowledge of basic mathematical calculations and rounding.
• Ability to perform basic computer operations (MS Office, email, Web Based Training).
• Familiarity or experience with cGMP within Biotech or Pharmaceutical operations a plus.

• May be required to wear PPE and other clean room garments daily.
• May need to remove makeup, jewelry, contact lenses, nail polish, and/or artificial nails in the manufacturing environment.
• Work in a cold, wet environment and across multiple shifts, including weekends or supplemental hours as necessary.
• Work around chemicals requiring respiratory protection.
• Physical requirements include standing/walking, lifting up to 50 pounds, climbing, bending/kneeling, overhead reaching, and repetitive use of arms and wrists.
• Ability to work assigned shift (day or night) and occasional travel to offsite meetings or training.

Takeda is transforming patient care through novel specialty pharmaceuticals and patient support programs. We are a Global Top Employer that values an inclusive, collaborative workplace and strives to deliver Better Health and a Brighter Future.

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, marital status, veteran status, or other protected characteristics, in accordance with applicable laws.