Manufacturing Excellence Operator

Military Spouse Corporate Career Network•St. Louis, MO

4d•Onsite

About The Position

The Manufacturing Excellence Operator supports aseptic operations in a cleanroom environment. The role includes setting up, disassembling, changing over, and operating high-speed and other cleanroom equipment; preparing and sterilizing components and equipment; and supporting improvement and equipment asset-care activities. The operator follows current SOPs and cGMP standards and maintains aseptic practices throughout work in the processing area. This position is for second shift.

Requirements

High school diploma or GED and at least 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 use 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 preferred.

Responsibilities

Follow aseptic, sterile, and cGMP techniques and maintain cleanroom gowning requirements and aseptic practices 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 in accordance with applicable procedures.
Maintain accountability for drugs and raw materials (RMPs and RMCs).
Perform required accountability, documentation, and quality in-process testing, following 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 jams and perform required tabletop equipment adjustments.
Set up, tear down, and change over cleanroom isolated machinery.
Complete and maintain required training, meet assigned training deadlines, and demonstrate proficiency in job functions.
Participate in continuous improvement events and activities.
Assist maintenance technicians with equipment issues.
Perform assigned operator and equipment asset-care duties.
Perform other duties as assigned.