Manufacturing Associate I - Night Shift

Takeda • Brooklyn Park, MN

10d • $19 - $30 • Onsite

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 role works on a 2-2-3 rotating shift with working hours from 5:45 PM to 6:15 AM.

Requirements

• High school diploma or GED.
• Experience in GMP environment preferred.
• 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).
• Will be 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

• 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.
• Familiar or experience with cGMP within Biotech or Pharmaceutical operations a plus.

Responsibilities

• Perform dispensing, labeling, 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 management or guidance will 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.
• With general management performs/or assists with processing steps and manufacturing support activities by managing process parameters in batch record 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.
• Performs data entry into LIMS.
• Perform cleaning/sanitizing production equipment.

Benefits

• U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
• U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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