Manufacturing Associate I - Night Shift

About the role:

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.

How you will contribute:

• 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.

What you bring to Takeda:

• 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.

Important Considerations:

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily.
• Carrying weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materials.
• Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations.
• Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durations.
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations.
• Moving Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time.
• Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time.
• Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time.
• 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.
• On rare occasions, travel may be required to offsite meetings or training event.