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Sr Process Engineer

Provide manufacturing expertise to support Operations, such as project support, technical investigations, process support and troubleshooting, process optimization, and identifying and implementing quality and cost improvement initiatives. Serve as team member on all projects involving Oral Solid Dosage Production products. As new products are transitioned from development to commercial production, assume the responsibility of overseeing the technical implementation and ongoing support of the new product and processes. Provide the necessary resources to Project Teams during business development and project development for the purpose of review and oversight of the product and process development as it pertains to Manufacturing operations. Support and troubleshoot all Oral Solid Dosage Production manufacturing processes, equipment and procedures. Coordinate the investigation and resolutions for all manufacturing issues and problems. Assist, as needed, in deviations and hold investigations. Provide necessary resources and expertise to all assigned investigations in order to insure a timely and thorough resolution to these situations. Assist in authoring procedural revisions. Participate, as needed, for all compliance and audit activities that require production technical support. Work with production to identify areas where process improvements and new technology projects can be initiated, such as designing and performing experiments to evaluate equipment, materials, facilities, and procedures. Coordinate change control, documentation, and root cause analysis to address root causes for production anomalies associated with process or production inefficiencies. Develop plans and execute change activities. Support corporate projects, such as Lean Six Sigma and Compliance initiative. Train junior staff. Perform other duties as assigned

  • BS in a scientific or production related discipline with 5 years relevant experience.
  • Strong knowledge of domestic and international regulatory requirements and pharmaceutical manufacturing processes.
  • Expertise in the theory and principals of solid dosage manufacturing as well as hands on familiarity with processing equipment is required.
  • Demonstrated creativity in designing novel solutions to complex technical problems and expertise in technology transfers and development approaches as applicable to area.
  • Ability to collaborate with co-workers and clients to meet goals.

Location: North Carolina

 

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