Manufacturing Excellence Operator- 2nd Shift

Kindeva•Bridgeton, MO

About The Position

In a clean room environment, the Manufacturing Excellence Operator supports activities associated with aseptic operations. This includes setting up, disassembling, and operating high-speed equipment; preparing and sterilizing components and equipment; and supporting improvement and equipment asset-care activities. The operator must follow current SOPs and cGMP standards, as well as aseptic and sterile techniques.

Requirements

High school diploma or GED and a minimum of 2 years of related experience.
Ability to read and comprehend instructions, correspondence, and technical documents.
Ability to present information effectively in one-on-one and small-group situations to other employees.
Ability to add, subtract, multiply, and divide using whole numbers, common fractions, and decimals.
Ability to calculate percent accountability, reconcile numerical values, and calculate bulk density.
Proficiency in operating computerized systems and software.
Ability to apply common-sense understanding to follow written, oral, or diagram-based instructions.
Ability to follow and review detailed documentation for accuracy and completeness.

Nice To Haves

Associate or technical degree.

Responsibilities

Follow aseptic, sterile, and cGMP techniques, including cleanroom gowning requirements and aseptic principles in the Processing Area.
Check cleanroom and filling processes for compliance with cGMP and departmental procedures, and report problems to the department supervisor.
Sanitize cleanroom areas according to applicable procedures.
Maintain accountability for drug and raw materials, including RMPs and RMCs.
Perform required accountability, documentation, and quality in-process testing according to applicable SOPs, batch records, and logbooks.
Unload sterilizers; handle and receive components; verify counts; and assign components to batches.
Prepare solutions for other departments.
Perform housekeeping duties according to SOPs.
Operate assigned machines and equipment and aseptically hand-assemble components.
Clear equipment jams and perform required tabletop adjustments.
Set up, tear down, and change over cleanroom isolated machinery.
Complete and maintain position training requirements, demonstrate proficiency, and remain current with assigned training.
Participate in continuous improvement events and activities.
Assist maintenance technicians with equipment issues.
Perform assigned operator and equipment asset-care activities.
Perform other duties as assigned.