Please note this is a 4 month contract position. Skills: Manufacturing experience, MS Office, GMP, PLC Programming experience, FDA Regulated Environment The Manufacturing Engineer will be responsible for: Closing aged non-conformances/aged CAPA’s including creation and maintenance of trending reports Closing aged Change Orders (CO) including creation and maintenance of trending reports Assisting in resolving Column Agglutination Technology Process Challenges Participating in technology improvements and Quality System enhancements Equipment Reliability and Utilization Assisting in developing robust processes Participating in Technology Improvement projects The individual will also identify top drivers for aged non-conformances and change orders and implement immediate corrective actions. The Manufacturing Engineer will plan, determine funding, and coordinate manufacturing projects as assigned to meet all performance requirements including cost, quality, safety and environmental criteria. The individual will work in direct support of the Raritan business operating units and designated project teams to support equipment upgrades, and process improvements. Responsibilities will include developing, coordinating, documenting, and delivering equipment with the associated regulatory and change management actions related to projects. cGMP responsibilities will be directly associated with quality system requirements of owning and managing quality events related to process and facility equipment corrective and preventive actions. Qualifications Requires minimum of a Bachelors degree in Engineering plus a minimum of 3 years of medical device and/or pharmaceutical facilities and/or manufacturing project management experience. Demonstrated ability to quantify, document, and evaluate functional requirements for production and facility systems as required. Must be knowledgeable of cGMP based process and equipment validations. Must have a working knowledge of all applicable engineering disciplines and project controls required in the successful design and construction of production and facility systems. A high level knowledge in the following areas is desirable: PLC programming, vision systems, labeling equipment, and automated filling, packaging and assembly equipment. Demonstrated understanding of Lean and Six Sigma principles is desirable. Candidate must possess written and verbal communications skills in formulating and communicating technical objectives into viable, justified capital projects. Interpreting and communicating technical content related to system design, function, and performance to management and auditing agencies is required. Knowledge of FDA and other regulatory guidance is helpful inclusive of commissioning, qualification and validation. Experience in device and/or pharmaceutical manufacturing processes leading to project implementation is required. Proficiency in Microsoft MS Office Suite (Word, Excel, Project, and PowerPoint) is required. This position will be based in Raritan, NJ. For consideration please include Job# 1499.
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