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Job Description

Job Title: Manufacturing Technician II

Location: Social Circle, GA

About the role:

The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, he/she may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during t he transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.

How you will contribute:

• Prepare media and buffer solutions.

• Operate Clean-in-Place (CIP) and Steam-in-Place systems.

• Assemble and operate filtration systems.

• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.)

• Monitor and record critical process parameters.

• Complete all relevant paperwork following GDP/GMP guidelines .

• Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.

• Perform sampling using aseptic techniques.

• Participate on Continuous Improvement Teams.

• Train and mentor other team members.

• Write, revise and review pertinent documentation as appropriate.

• Troubleshoot process problems and respond to process alarms.

• Assist with process/equipment validation and data analysis.

• Work with other groups such as maintenance/metrology to ensure preventative maintenance is done.

• Initiate and/or coordinate other process improvement projects.

• May perform other duties as assigned.

Inventory Technician:

• Responsible to execute material transfers that include non-hazardous, hazardous and flammable chemicals to support manufacturing schedule adherence.

• Maintain a visual replenishment program of materials using lean manufacturing

• processes/tools.

• Maintain records of materials in inventory and on order.

• Compile inventory records as needed.

• Reconcile discrepancies in inventories.

• Compile information on receipt and transfer of materials.

• Resolve questions and problems and refers only most complex issues to higher levels.

• Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS). Understand and follow Job Hazard Analysis (JHA) packets.

What you bring to Takeda:

• Requires high school diploma or GED plus 2+ years of experience or associates’ degree or higher and 1+ years of related work experience.

Key Skills, Abilities, and Competencies

• Knowledge of cGMP manufacturing.

• Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.

• Must be able to apply quantitative analysis to analyze process performance.

• Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.

• Must be able to read and fol