TECHNICIAN 2-0227140127
Description
Ortho Clinical Diagnostics, a member of the Johnson & Johnson's Family of Companies, is recruiting for Manufacturing Technician 2 located in Raritan, NJ.
Ortho Clinical Diagnostics serves medical laboratories and the transfusion medicine community around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.
This position is responsible for performing manufacturing procedures and executing diverse tasks in various manufacturing areas related to formulation, filtration, purification, reagent preparation, processing of plasma/serum by absorption and protein fractionation, Viresolve and Viral Inactivation processes according to detailed operational specifications and execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.
Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum. Support schedule adjustments to meet production, material receipt and shipping requirements and review schedule. Perform and understand detailed processes to include: filtration, reagent and diluent preparations, plasma processing, fractionation, virus removal through filtration and chemical viral inactivation Perform in-process testing as required by processes and procedures utilizing instrumentation, such as: (pH meters, spectrophotometers, viscometers, conductivity bridge, flame photometers, scales, deionization columns and pumps) list is not all inclusive. Knowledge and understanding of test methods and interpretation of results. Understand Lean principles as it relates to work. Understand Value Stream maps and relevancy. Actively participates in Kaizen, problem solving and ME2 activities. Work with Production Planner/Team Leader to review departmental production schedules, work orders and related information to ensure materials are available for production. Verify and enter production parameters per SOP and Batch Records. Accurately complete documentation in batch records, logbooks, forms and other GMP documents. Assure manufacturing facility and equipment meets all requirements prior to production on all shifts. Clean, prepare and assemble equipment for processing operations including stationary tanks, filter housings, collection vessels, centrifuges and mixing apparatus. Operate and troubleshoot equipment in clean room and non-clean room environment. Review progress reports concerning status and downtime of machines and equipment and apprises Production Planner of delays. Monitor environmental conditions inside and outside classified rooms. Use of ERP system for performing material transactions/moves/quantities/cycle counts. Demonstrate training progression through assigned curriculum. Revise and review specifications and keep them up to current standards and practice. Knowledge of cGMP requirements to ensure adherence to compliance policies and regulations. Wear the appropriate PPE when working in manufacturing and other hazardous working environments. Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors. Performs and has good understanding of processes and procedures. Assist with validation activities within the area. Assist or may lead troubleshooting of routine manufacturing equipment and processes and notifies supervision of any issues. Good technical knowledge within functional area and understanding of upstream/downstream processes. Demonstrate a good understanding of the process in order to properly perform the assigned manufacturing tasks. Identifies discrepancies or trends that might need additional attention and notifies supervision. Needs some direction to perform manufacturing daily tasks within functional area. Performs and has good understanding of processes and procedures. Assist with validation activities within the area. Assist or may lead troubleshooting of routine manufacturing equipment and processes and notifies supervision of any issues.
Qualifications
Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience. Associates Degree or Equivalent. Good working knowledge and understanding of systems as required. Utilizes tools within MS Office and other systems to improve business effectiveness. Accurate Data Entry skills in ERP system While performing the duties of this job, the employee needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Is frequently required to communicate with coworkers. While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time. Ability to lift up to 40 lbs. Needs to perform gowning procedures to work in manufacturing core or classified rooms. Work with blood, blood products and chemicals. Work in a cGMP area and/or clean room environment. Must pass vision acuity test for inspection of work in process and finished goods. Overtime is required, as necessary. Shift work may be required, as necessary. Ability to read, write and speak English. Read and interpret documents such as safety rules, operating instructions and logbooks. Review and provide feedback for SOP and Batch Record Revisions. Good communication and written skills. Interpret a variety of instructions furnished in written, oral, diagram or schedule form. Follow instructions, strong understanding of processes and interpretation of results. Solve practical and complex problems and deal with a variety of concrete variables in situations where only limited standardization exists. Add, subtract, multiply and divide in all units of measure, using whole numbers, common factions, and decimals. Knowledge and ability to operate manufacturing, manufacturing-support and lab equipment. Knowledge of Process Excellence Tools. Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
Primary Location:North America-United States-New Jersey-Raritan
Organization: OCD Inc. (6118)
Job Function: Production
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