This position is located in Mt. Vernon, Indiana. 1)Responsible for providing pharmaceutical process support to new and existing oral solid dosage form (tablet and capsule) products/processes. Responsible for associated process and cleaning validation activities. 2)Enhances quality and effectiveness of manufacturing systems related to existing products. Supports the design, execution and evaluation of experimental plans to ascertain the required process capabilities, specifications and robustness. 3)Optimizes existing manufacturing processes in alignment with the site initiatives (i.e. cycle time, cost reduction, optimized equipment performance and efficiency) and manufacturing operational needs and in alignment with Regulatory groups to support process changes and optimization projects. 4)Conducts statistical process control and process capability analysis for existing products. Utilize statistical tools and other techniques to assess products/process performance for existing products. 5)Investigates and conducts troubleshooting and root cause analysis of unexpected trends or results related to product quality and financial aspects (i.e. yield) due to material and/or process related factors during the daily support to site operations. Implements accurate and timely solutions and develops and manages plans as needed. 6)Responsible for the technical aspects of studies and implementation of strategies and plans. Leads the enhancement of manufacturing equipment and facilities, introduction of state of the art technologies, and / or enhancement of site manufacturing capabilities associated to new and existing product projects. 7)Executes site PAT strategy to monitor and control existing manufacturing processes. 8)Participates in and supports regulatory (internal & external) audits.
BS degree in Chemical Engineering , Industrial Pharmacy or equivalent with 3-5 years experience supporting pharmaceutical manufacturing of oral solid dosage products preferred. Good listening skills and good oral and written communication skills are a must. Must be effective at collaborating with others to obtain the desired organizational objectives. Requires a high degree of initiative and ability to work with minimal supervision.
Job Function: Quality
Primary Location: NA-US-IN-Mt. Vernon
Nearest Major Market: Evansville
Job Segments: Chemical Engineer, Engineer, Engineering, Healthcare, Law, Legal, Manufacturing Engineer, Pharmaceutical, Pharmacy, Process Engineer, Science
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