TOLMAR Inc. Manufacturing Technician II - Aseptic in Windsor, Colorado
Purpose and ScopeThe Aseptic Technician II provides technical support for the manufacturingdepartment with a focus on injectable products. They provide manual assistanceto the team while ensuring that products are made with quality for ourpatients.Key Responsibilities Perform job responsibilities in accordance with standard operatingprocedures (SOPs) and production records with an expectation of "Rightthe First Time". Record data in notebooks or lab forms and accurately calculate results tosupport process. Perform job in a clean room environment requiring clean room gowning,including but not limited to:o Company-provided Scrubso Shoe Covers and Sterile boot coverso Hairnets (and beard covers as applicable)o Tyvek Coverallso Gloveso Face masko Goggleso Chemical Protection PPE Set up and operation labeling equipment used to label pre-filled syringesand/or vials, including equipment in the sterile support areas. Properly load pre-filled syringes and/or vials into labeling equipment. Set up and operate semi-automatic packaging equipment used to packagepre-filled syringes. Properly load pre-filled syringes and components into semi-automaticpackaging equipment. Accurately document production activities using regulatory controlleddocuments including production records and log books. Properly perform job duties as a second-checker, ensuring all productionactivities are correctly performed per batch production records. Perform minor maintenance and setup on aseptic production equipment. Handle hazardous raw materials and cleaning solutions following allapplicable safety procedures and policies. Maintain proper use of aseptic techniques. Perform facility cleaning of critical aseptic environment as required tomaintain a cGMP environment and in accordance with Standard OperatingProcedures. Ensure that product quality adheres to approved specifications. Perform 100% inspections on pre-filled syringes. Train less experienced Aseptic Technicians on aseptic manufacturingprocedures. Perform visual and physical checks of in-process and finished product asrequested. Responsible for assembly, disassembly and sanitation of various equipment. Operate under consistent supervision of a Lead Operator and/or AsepticSupervisor. Perform other duties as assigned.Requirements Special Skills and Knowledge Working knowledge of current Good Manufacturing Procedures (cGMP). Ability to stand for extended periods of time (up to 8 hours or more). Understanding of basic computer software. Maintain focus on detail-oriented, repetitive tasks. Ability to follow and understand written production records and validationprotocols. Understanding of basic math and writing skills to document productionactivities in batch records and/or log books. Must be able to keep accurate records and able to perform mathematicalcalculations. Ability to legibly complete required documentation. Strong attention to detail required for documentation in productiondocuments. Ability to be respirator-qualified and wear respirator for extendedperiods of time (up to 4 hours) while performing cleaning of area. Capability to operate on a fast-paced manual assembly line using basicproduction equipment. Ability to manually assemble components. Ability to lift up to 40 lbs. Ability to lift arms above shoulder height repetitively for duration ofshift during periods of area cleaning.Communication Interact with peers and members of other departments in team settings in aprofessional manner.Education & Experience High school diploma or equivalent required. 1 or more years of experience in a GMP manufacturing environment.Additional Requirements Acceptable results on both a quantitative and verbal assessment test. Valid driver s license and acceptable motor vehicle record may be required. Shift work in a manufacturing and warehouse environment. May require overtime.