TOLMAR Inc. Manufacturing Technician II - Aseptic Development in Windsor, Colorado

Purpose and ScopeThe Aseptic Development Technician II provides technical support for themanufacturing department with a focus on development of injectable products,while ensuring that products are made with quality for our patients.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 Goggleso Face masko Chemical protection PPE Set up and operate 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. Perform facility cleaning of manufacturing areas as required to maintain acGMP environment and in accordance with Standard Operating Procedures. Properly perform job duties as a second-checker, ensuring all productionactivities are correctly performed per batch production records. Ensure that product quality adheres to approved specifications. Identify the need for minor maintenance on aseptic production equipmentand assist with set-up. Assist and support any aseptic process development activities/projectsas determined by Aseptic Development Operations Manager. Handle hazardous raw materials and cleaning solutions following allapplicable safety procedures and policies. Correctly perform inspections of packaged components. Perform minor maintenance and setup on aseptic production equipment. Responsible for assembly, disassembly and sanitation of various equipment. Review and maintain log books, production records, and associateddocuments to comply with regulatory requirements, GMPs, and TOLMARStandard Operating Procedures. Perform visual and physical checks of in-process and finished product asrequested. Train new manufacturing employees to perform manufacturing processes. Assist with the formulation of bulk materials. Perform other duties as assigned.Special Skills and Knowledge Working knowledge of current Good Manufacturing Procedures (cGMP) asthey relate to production packaging activities in an aseptic environment. Ability to stand for extended periods of time (up to 8 hours or more). Understanding of basic computer software. Ability to 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. Ability to keep accurate records and able to perform mathematicalcalculations. Ability to legibly complete required documentation. Strong attention to detail required for documentation in productiondocuments and to inspect produced goods within specified requirements. Capability to operate on a fast-paced manual assembly line using basicproduction equipment. Ability to learn Aseptic technique and work in an aseptic environment. Ability to wear respirator for extended periods of time while working ontasks (up to 4 hours). Ability to lift up to 40 lbs. Ability to lift arms above shoulder height repetitively for duration ofshift while cleaning.Communication Ability to interact with peers and members of other departments in teamsettings in a professional manner.Education & Experience High school diploma or equivalent required. One or more years of experience in a GMP manufacturing environmentrequired. One or more years of experience in an aseptic (sterile) manufacturingenvi