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KLINEXA is a scientifically focused contract research organization that provides pharmaceutical, biotechnology and medical device companies with a full range of services.

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Network Qualification Engineer

Job Summary
Our Client is seeking a Network Qualification Engineer for a contract position.  The successful candidate will perform IT infrastructure activities for a medium sized network using best practices in life science industry, author qualification related documents, review company SOPs and set up processes or provide direction for maintaining network in qualified state. 
 
Job Requirements
  • Knowledge of FDA, GAMP and European guidelines for infrastructure qualification.
  • Knowledge of GLP regulations.
  • Solid understanding and experience with network technologies, systems and infrastructure.
  • Infrastructure qualification experience including networks, servers, software, network related hardware and software systems.
  • Good understanding of disaster recovery processes and practices. 
  • Proficient in technical writing of validation/qualification documents.
  • Related project management experience.
  • Current knowledge of life science industry expectations.
  • Must be current on best industry practices for applicable projects.
  • Thorough knowledge of qualification/validation activities.
  • Some understanding of IT quality management metrics.
Minimum Qualifications
  • Bachelor’s Degree
  • 4-5 years of experience in qualification/validation projects in life science industry.
  • Experience working with network devices and related software systems.
  • Must be a team play and motivated. 
This is a contract position for estimated six months to one year in length or until project has been completed. 
 
This position is located in Bedford, MA.
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