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Sr. Engineer
Ref No.: 18-15326
Location: Thousand Oaks, California
Position Type:Prof (T)
Start Date / End Date: 10/09/2018 to 04/09/2021
Our client, a leading biopharmaceutical company is looking for a Sr. Engineer. This is for an initial duration of 2+ years and is located in Cambridge, MA or Thousand Oaks, CA
 
Top Skill Sets:
  • Well versed in chemical engineering fundamentals
  • Process development
  • Regulatory requirements and scale up
 
Description:
  • The ideal candidate will have expertise in tech transfer, process development, modeling, optimization, characterization, regulatory support and commercial production of synthetic organic molecules.
 
Basic Qualifications:
  • Doctorate Degree OR
  • Master’s degree and 3 years of Engineering or Operations experience OR
  • Bachelor’s degree and 5 years of Engineering or Operations experience OR
  • Associate’s degree and 10 years of Engineering or Operations experience OR
  • High School Diploma/GED and 12 years of Engineering or Operations experience
 
Preferred Qualifications:
  • Engineer with 5+ years of experience in providing and driving engineering deliverables for pharmaceutical processes and product development
  • Experience related to process development, technology transfer, scale-up and manufacturing of synthetic molecules in regulated environment. This includes technical support for nonconformance investigations and other commercial support activities
  • Ability to critically evaluate chemical processes for identification of process improvements and requirements necessary for scale up and tech transfer
  • Possess strong understanding of regulatory and cGMP requirements
  • Knowledge of analytical techniques and solid-state characterization with fluency in a wide variety of analytical techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, particle size determination, etc.
  • Able to apply engineering principles and advanced statistical analysis in-order to solve processing issues and evaluate opportunities for process improvements
  • Experience building and utilizing first principle models (reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms
  • Experience in working closely with process development chemists, formulation scientists and analytical chemists to generate and interpret data to provide enhanced understanding and guidance for synthesis and unit operations
  • Contribute to key regulatory and quality activities such as non-conformances, process performance qualification and continued process verification
  • Experience with Quality by Design and Process Analytical Technologies, applied to pharmaceutical development
  • Strong communication and presentation skills, excellence in team work, mature process fit proficiency, command of operations plant safety practices
  • Fluency in German and/or Italian is a plus
 
Qualified candidates please send your word format updated resume at the earliest to sangeeth.k@sunrisesys.com.  Thank You.