Manufacturing Excellence Operator

VetJobs•St. Louis, MO

1d•$60,000 - $75,000

About The Position

Kindeva is hiring a Manufacturing Excellence Operator for its St. Louis, Missouri team. In a clean room environment, this role supports activities associated with aseptic operations, including setting up, disassembling, and operating high-speed equipment; preparing and sterilizing components and equipment; and participating in improvement and equipment asset-care activities. Work must follow current SOP and cGMP standards. This position is for second shift.

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, and to present information effectively in one-on-one and small-group situations.
Ability to perform arithmetic using whole numbers, common fractions, and decimals, and to calculate percent accountability, reconcile numerical values, and calculate bulk density.
Proficiency operating computerized systems and software.
Ability to apply common-sense understanding to carry out written, oral, or diagrammed instructions.
Ability to follow and review detailed documentation for accuracy and completeness.

Nice To Haves

Associate or technical degree.

Responsibilities

Follow all aseptic, sterile, and cGMP techniques.
Meet cleanroom gowning requirements and adhere to aseptic technique 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 (RMPs and RMCs).
Perform required accountability, documentation, and quality in-process test result reviews and activities in accordance with applicable SOPs, batch records, and logbooks.
Unload sterilizers; properly 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 jams and perform tabletop equipment adjustments.
Set up, tear down, and change over cleanroom-isolated machinery.
Complete and maintain position training requirements within assigned target times and demonstrate proficiency in required job functions.
Participate in continuous improvement events and activities.
Assist maintenance technicians with equipment issues and perform assigned operator and equipment asset-care activities.
Perform other duties as assigned.