Manufacturing Excellence Operator- 2nd Shift

Kindeva Drug Delivery•Bridgeton, MO

About The Position

In a clean room environment, the Manufacturing Excellence Operator 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. The role requires following current SOPs and cGMP standards and maintaining aseptic practices throughout work in the Processing Area.

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 effectively present information in one-on-one and small-group situations to other employees.
Ability to perform arithmetic with whole numbers, common fractions, and decimals, including percentage accountability, numerical reconciliation, and bulk density calculations.
Proficiency operating computerized systems and software.
Ability to use common-sense understanding to carry out 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 and maintain cleanroom gowning 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; properly handle and receive components, verify counts, and assign components to batches.
Prepare solutions for other departments.
Perform housekeeping duties in accordance with 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 required training, meet training target times, and demonstrate proficiency in job functions.
Participate in continuous improvement events and activities.
Assist maintenance technicians with equipment issues and perform assigned operator and equipment asset-care tasks.
Perform other duties as assigned.