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Job #03642

About our client Our client is an established leader in the contract manufacturing sector that provides outsourced services to pharmaceutical and personal care companies. They boast an experienced management team and a 30-year track record of innovation, quality and reliability. This is a unique opportunity for a savvy engineering professional that wants to put their drive and initiative to work for a highly reputable company with a bright future. Position Location Process Engineer California Salary Highly competitive package, commensurate with experience Responsibilities 1) Maintain and improve technically sound and cost-effective manufacturing processes in compounding 2) Conduct process capability studies on existing product and provide direction for improvements 3) Provide a proactive technical interface with Research and Development and Compounding Department 4) Review all current production processes retrospectively 5) Devise improved detailed methods for production 6) Ensure documentation is properly completed to meet regulatory, customer and quality system requirements 7) Trouble shoot and work on NCRs and Corrective and Preventative Actions (CAPA) 8) Conduct studies and experiments with materials, vendors, processes, supplier services and recommend changes in procedures to improve quality, service and or reduce cost 9) Assist in equipment selection, design and installation in the process development and manufacturing plants 10) Support GMP compliance efforts 11) Review product history data for equipment and bulks to improve equipment parameters, recommend and implement changes to improve cycle time, changeovers, reduce downtime and ensure safety 12) Lead projects to drive desired results in the Compounding Department 13) Reengineer processes and systems to improve compounding throughput and efficiencies 14) Support growth and continuous process/documentation improvement efforts 15) Coach and educate compounders on the effects of mixing, chemicals, and reactions in formulations 16) Give feedback to R&D and Compounding management on new product technical transfers Requirements 1) Bachelor’s degree in Chemical Engineering or Chemistry 2) Minimum 5 years of process engineering experience with expertise in compounding, research and development and/or quality 3) Experience as a Process Engineer or a Manufacturing Engineer in personal care, nutraceutical or OTC pharma 4) Working knowledge of FDA regulations pertaining to over-the-counter drug manufacture, testing, validation and documentation 5) Excellent analytical skills and problem-solving ability 6) Good written and verbal communication skills