Associate Engineer

Thousand Oaks, California 91320 | Contract

Post Date: 01/17/2018 Job ID: 3769 Industry: Biotech

As a member of the process development team, this role will be focused on characterizing new formulation fill finish technologies and advancing the state of the drug product manufacturing process. The candidate will perform experiments, organize data and analyze results with minimal supervision. The candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups. 

Engineer responsibilities include, but are not limited to, the following: 
  • Independently execute experiments in order to characterize and enable implementation of new capabilities that advance state-of-the art automation, high throughput screening, formulation, filling, lyophilization and analytical technologies 
  • Serve as single point of contact and subject matter expert (SME) on complex capabilities. Enable walk-up utilization and own business process. 
  • Independently design and execute process development studies to characterize formulation, filling, lyophilization, capping, and inspection operations to deliver robust manufacturing processes and drug products 
  • Apply fundamental scientific (biochemistry, biophysics, statistics, etc.) and engineering principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials 
  • Conduct analysis of data generated from any of the above listed activities, including statistical analysis using SAS, JMP etc., and effectively communicate results 
  • Troubleshoot malfunctioning equipment, work with Lab Ops, Asset Management, Facilities and vendors to repair 
  • Author/review technical documents, such as technical protocols, technical assessments, technical reports, regulatory documents 
  • Perform tasks related to safety and compliance initiatives in the lab. 
  • Manage procurement and inventory levels of commonly used lab supplies and chemicals 


Preferred Qualifications: 
  • B.S. with 4? 6 years of industry experience, M.S. with 3? 4 years’ experience, with degree in Engineering 
  • Displayed critical thinking, problem solving and independent research skills 
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies 
  • Good computer and organizational skills with strong attention to detail 
  • Excellent communication (oral and written) 
  • Excellent project management skills including the ability to manage project resource requirements material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management 
  • Self-motivation, adaptability and a positive attitude 
  • Ability to work independently and as part of a team with internal and external partners 
  • Experience working in GMP environments or process development
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