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TI
Tolmar Inc.
Manufacturing Operator I - Injectables
Career Insights for Manufacturing Machine Operator (General)
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What they do
A Manufacturing Machine Operator operates machinery used in a manufacturing facility, including a range of machines used for the production or transport of goods.
$39,372 / year median in Colorado
+6% projected growth
Job Description
Core Hours Monday - Friday, 6:00 am - 2:30 pm Purpose and Scope The Injectable Operator I performs routine activities related to supporting the injectable team, while ensuring products are made with quality for our patients. Essential Duties & Responsibilities Perform job in a clean room environment requiring clean room gowning Perform setup/operations/disassembly/trouble-shooting of labeling equipment used to pre-filled syringes and/or vials, including equipment in the sterile support areas. Perform setup/operation/disassembly/trouble-shooting of semi-automated packaging equipment used to package pre-filled syringes. Assist in the Setup/Disassembly/Cleaning/trouble-shooting of syringe filler. Perform in-process sampling, testing and inspection on the packaging line. Ensure that product quality adheres to approved specifications. Perform syringe inspections using SIE (Syringe Inspection Equipment). Assist in setup data acquisition program for in-process testing for syringe filling. Operate data acquisition program for in-process testing for syringe filling. Perform setup/execution/disassembly for small bulk processing. Stage production lots for processing. Perform setup/execution/cleanup of needle cleaning process. Perform cleaning and environmental monitoring of process rooms. Order Supplies. Perform job responsibilities in accordance with standard operation procedures (SOPs) and production records with an expectation of "Right the First Time." Train less experienced technicians. Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures. Perform other duties as assigned. Knowledge, Skills & Abilities Working knowledge of current Good Manufacturing Procedures (cGMP). Interact with peers and members of other departments in team settings in a professional manner. Understanding of basic computer software. Ability to follow and understand production records and procedures. Understanding of basic math and writing skills to accurately document production activities in batch records and/or log books. Attention to detail is required for documentation in production documents. Capability to operate on a fast-paced manual assembly line using basic production equipment. Ability to manually assemble components. Ability to stand for extended periods of time (up to 8 hours). Ability to lift up to 40 lbs. Ability to perform activities above your head. Successfully qualification of internal syringe visual inspection program. Core Values The Manufacturing Operator I - Injectables is expected to operate within the framework of