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PMN Technical Services Engineer II - United States  

Company managed [?] Still accepting applications
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Posted on : 29 May 2017

Project Description

Job Description 
Provide life cycle support for solid dose and liquid pharmaceutical from protoype development through the life of commercialized product. 

Major Responsibilities:  
  • Completes technical assessments and investigations for commercial products.  
  • Manages tech transfer, scale up, and optimization of newly developed products from R&D to the Operations groups.  
  • Revise existing Manufacturing Orders, Ingredient Disclosures, Excipient Threshold Limits, to support process optimizations. 
  •  Run commercial scale formulation and scale-up work, perform developmental trial batches to support post launch submissions.  
  • Manage projects to support MRB, PEM, and PPT. 
  • Lead and drive execution of manufacturing projects to support life-cycle changes including infancy/monitoring programs for new product launches and implementation of corrective and preventative action in response to process failure investigations. 

Required Experience 
  • Ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines. 
  • Must possess in depth knowledge of principles, concepts and practices in pharmaceutical sciences and manufacturing processes. 
  • Interpersonal, organization and communication skills, ability to work effectively with staff members at all levels, strong technical writing skills, familiarity with cGMP and FDA regulations. 
  • Understanding of development and/or reformulation of tablet and liquid formulas required.Computer literacy with a working knowledge Microsoft Office (Excel and Word), with SAP experience. 
  • Demonstrated ability to work independently on multiple concurrent projects with minimal guidance and to meet project deadlines.  
  • Bachelor’s degree in Engineering, Chemistry, Pharmaceutical sciences or related field, with two to five years of practical pharmaceutical process support engineering experience.  
  • Bachelor's degree required: consideration may be given to those who hold 8+ years of progressively responsible and relevant work experience. 
  • Masters degree in Engineering, Chemistry, Pharmaceutical sciences and Yellow-belt Lean Sigma Status preferred but not required.