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Sr. Validation Engineer
Ref No.: 17-23095
Location: Lake Forest, Illinois
Immediate need for a Sr.Validation Engineer  with experience in the Pharma  Industry. This is a 12  months contract opportunity with long-term potential located in Lake Forest,IL . Please review the job description below:


Job ID: 17-23095

 
 Key Responsibilities/ Key Requirements and Technology Experience:

 
  • Differentiated Drug Delivery (DDD) is a combination product design and development organization focused on improving patients’ lives through customer-focused innovation and broad-based access to quality medicines and products.
  • This role has primary responsibility for confirmation that medical devices and combination
  • products meet their intended function.
  • This includes development of data through engineeringstudies that informs new product development as well as test reports that support productsubmissions.
  • The candidate will work within a team environment to solve problems and utilize best engineering practices and techniques for root cause and statistical analysis.
  • This work entailsdefining test methods, developing protocols, performing data analysis, and writing reports incompliance with corporate procedures.
  •  Partner with Systems engineers in defining product requirements such that they are verifiable
  •  Development of test fixtures, test methods, and performance of Test Method Validation activities
  •  Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
  •  Ensure integrity and compliance of data according to Standard Operating Procedures
  •  Develop Verification Plans including test strategy
  •  Utilize technical writing and statistical data analysis skills to write protocols and reports
  •  As necessary, conduct root cause analysis and derive recommendations based on analysis of data
  •  Translate inspections and tests methods into component and product specifications
  • B.S. in Engineering or science discipline and 2 to 5 years related experience.
  • Familiarity with ISO standard test methods and related test instrumentation preferred.
  • Excellent analytical and communication skills required.
  • Ability to work and solve problems in team environment.
  • Technical writing skills are required for protocol and report writing.
  • Physical requirements include walking, standing, and performing analysis including protocol and
  • report writing. Includes hands-on test method development.


Our client is a leading Pharma Industry and we are currently interviewing to fill this and other similar contract positions. Qualified candidates should apply online for immediate consideration.