KBI: US - Manufacturing Associate I

Primary Responsibilities

• Manufacture cell culture products according to manufacturing batch records while ensuring compliance with quality standards, company policies, and current regulations.
• Perform cleanroom operations, adhering to aseptic processing controls, including gowning and cleaning procedures.
• Document manufacturing procedures (e.g., SRs, EPRs, BRs) in compliance with Good Documentation Practices (GDP) at the time of execution.
• Ensure proper issuance and accountability of items used in manufacturing records (SR, EPR, BR).
• Demonstrate and apply knowledge of current Good Manufacturing Practices (cGMP) in daily tasks and responsibilities.
• Maintain and uphold 5S standards in the manufacturing environment.
• Operate and perform maintenance on equipment per applicable Standard Operating Procedures.

Minimum Requirements

• Manufacturing Associate I: Bachelor's degree in a related scientific or engineering discipline with 0-2 years of GMP manufacturing experience; OR high school diploma with 3-5 years of related GMP manufacturing experience.

Reasoning Ability

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Math Ability

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Physical Demands

• Standing and sitting for long periods of time may be required at times.
• Lifting, pushing, and pulling may be required for stocking and movement of equipment.
• The use of ladder may be required when setting up bioreactors.

WORKING CONDITIONS

• The job requires working 12-hour shifts which may include working overnight.
• The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations.
• Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene.
• While performing the duties of this job the employee regularly utilizes equipment and materials which include mechanical hazards, chemical hazards, electricity hazards, and tripping and falling hazards.
• The noise level in the environment is moderate to high.