US-CA, Manufacturing Technician II SR0031479-MZ
The Manufacturing Technician II is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. The Manufacturing Technician II is expected to fully participate in both departmental projects and any quality working teams which may be applicable. Under the general direction of the lead technician and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all activities in the production area. This position initiates minor revisions to existing documents. The incumbent can troubleshoot simple existing procedures. All of the specific requirements presented in this job description are applicable to the functional area in which it resides. Essential Duties and Responsibilities Gowning and degowning for Packaging area. Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes. Responsible for Room sanitization, wrapping up components, operating autoclave, performing CIP/SIP of tanks, small parts washing Visual inspection of lyophilized product vials, Visual inspection of empty vials for glass defects, Visual inspection of empty vials for washout defects, visual inspection of rubber stoppers for defects Clean and sanitize manufacturing and associated support areas. Responsible for monitoring bioreactors and respond to alarms in all Cell Culture Suites. Responsible for monitoring the skids and respond to alarms in all Purification Suites. Record bioreactor, chart recorder readings, alarm response related to the bioreactor, skid performance, inoculums and emergency response during blackouts. Conduct documentation review Participate in Quality Working Teams and Continuous Improvement Teams Conduct visual inspection of needles and assemble needle packs. Operate pallet jack and shrink wrap Manually clean equipment and conveyors. Load/Unload materials to conveyors and packaging carousel. Responsible for Biodecontamination and appearance of all Manufacturing Production areas, Bulk Formulation, Aseptic filling, Sterility Test room, Final Container Drying and Preparation Production rooms. Prepare solutions in portable mixer. Operate production equipment such as pH meter and autoclaves. Monitor department equipment for proper operation. Stock department supplies Handling and Removal of Hazardous Waste Basic Computer Skills May perform safety and cGMP inspections or observations. Ensure compliance with SOP/cGMP and cGDP requirements. May assist in training of new employees. May assist in updated/revising SOP s. Complete relevant paperwork following GDP/GMP guidelines. Receive and distribute supplies into the production area as necessary. May perform other duties as assigned. Qualifications Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Knowledge of cGMP manufacturing and SOP s. Employee maybe required to manage hazardous wastes in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include: Identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes. Results oriented and possess the ability to work independently as well as within a team environment. Must have the ability to correctly complete high school-level mathematics. Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Must be able to read, write, and converse in English. Must be able to navigate, conduct searches, and fill on-line forms on Personal Computer for the purposes of training, performance management, and self-service applications. Must have the ability to navigate electronic mail systems and intranet for communication purposes. Must be self-motivated. Must have intermediate level computer skills. Good interpersonal skills and be able to work effectively and efficiently in a team environment. Knowledge of basic chemical and biological safety procedures. The incumbent must work in a controlled environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements. Basic Knowledge of Cell Culture, Purification, and Formulation/Filling operations and capabilities. Understands Manufacturing Production Process as it pertains to: Visual product integrity processes; Visual inspection of components, finished goods and imprinting; Manual and semi-automated packaging; Product labeling Understands Manufacturing Production Flows for all product lines. Understands the flow and design/interdependency of manufacturing support departments Knowledge of clean room management. Basic knowledge of microbiology. Knowledge of inventory management. Knowledge of manufacturing equipment operation, including set up and changeover, as well as commissioning, validation, and troubleshooting Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement. Education and/or experience Requires high school diploma with 1-3 years work experience. Physical Demands The overall physical exertion of this position requires medium to heavy work. May be required to sit between 1-2 hours in Bulk and F/F, for up to 1 hour in Suite A and over 4 hours in the Packaging area. May be required to walk between 3-4 hours in Bulk, over 4 hours in Suite A and F/F and between 1-2 hours in the Packaging area. May be required to stand between 3-4 hours in Bulk, for over 4 hours in Suite A, F/F, and Packaging. May be required to bend at the neck for up to 1 hour in Bulk, for over 4 hours in Suite A and F/F and between 3-4 hours in the Packaging area. May be required to bend at the waist for up to 1 hour in Bulk, between 1-2 hours in Suite A, over 4 hours in F/F and under 1 hour in the Packaging area. May be required to squat up to 1 hour in the Bulk, Suite A, and Packaging areas and between 1-2 hours in F/F. May be required to climb (use step stools and ladders) up to 1 hour in all Manufacturing areas. May be required to reach above/below the shoulder between 1-2 hours in Bulk, up to 1 hour in Suite A and Packaging and between 3-4 hours in F/F. May be required to kneel up to 1 hour in Bulk and F/F, between 1-2 hours in Suite A and up to 1 hour in the Packaging area. May be required to twist at the neck/waist up to 1 hour in Bulk and Packaging, between 3-4 in F/F, and over 4 hours it the F/F area. May be required to lift up to 75lbs in Bulk and up to 50lbs in the Suite A, F/F and Packaging areas. Lifts per shift vary between 2 times, up to 100 times in all Manufacturing areas. May be required to carry up to 25lbs in Bulk, F/F and Packaging and up to 50lbs in Suite A. Carry distance of up to 20ft in all Manufacturing areas. Carries per shift vary between 2 times, up to 100 times in all Manufacturing areas. Requires repetitive use of both right and left hands and arms between 3-4 hours in Bulk and F/F and for over 4 hours in Suite A and Packaging. May require simple grasping for up to 1 hour in Bulk, between 3-4 hours in F/F and over 4 hours in Suite A and Packaging. May require power grasping for over 4 hours in Suite A and F/F and up to 1 hour in the Packaging and Bulk areas. May require fine manipulation for over 4 hours in Suite A and Packaging, up to 1 hour in Bulk and between 1-2 hours in F/F. May require pushing/pulling with hands/arms between 1-2 hours in Bulk and Packaging, between 3-4 in F/F and over 4 hours in Suite A. May require office work activities with hands/arms up to 1 hour in Bulk and Suite A, between 1-2 in F/F and over 4 hours in the Packaging area. May be required to gown frequently and balance when gowning into clean areas. May be required to drive a car, truck, forklift and other equipment in the Packaging area May be required to work around moving equipment and machinery in all Manufacturing areas. Will not be required to walk on uneven ground. May be exposed to noise above 85 dBA in Bulk and Suite A. This may require hearing protection and other protective equipment to be worn. May work and have exposure to hot, cold, wet environment/conditions in all Manufacturing areas. May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection. May be required to work at heights above floor level. Will not be required to operate foot controls or repetitive foot movement. May require the use of special visual or auditory protective equipment in Bulk and F/F areas. May be required to work with biohazards such as: bloodborne pathogens, seage or medical waste in the F/F areas. May be required to drive to travel to other facilities, training sites, and off site meetings. May be required to work in confined areas. Will require entering a 2-8 degree Celsius & -60 degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg such as IPA, 500ppm sodium hypochlorite in the F/F area. Working Environment This position requires shift, weekend and holiday work. Must be able to work in controlled unclassified environment requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments. Inside working conditions. Overtime may be required at times. May be required to work or be assigned to a different shift as needed. Must be able to work more than 8 hours a day or 40 hours a workweek as required. Will have interaction with other people. Pace may be fast and job completion demands may be high. Position requires usage of computer.
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