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"When I was still in college and working at RTI as an intern, I knew it was somewhere that I wanted to work full-time one day. RTI holds its employees to the highest standards, which allows for continuous growth both professionally and personally. I love being able to walk around campus and be immersed in a community of knowledgeable, hard-working innovators who all have a primary goal of improving the human condition." Lily Duchesneau Financial Analyst- SSES Strategic Pricing Group
"It is a pleasure to be part of a company that has such a positive outreach and works to improve the human condition. With a great reputation in the local community and abroad, it is easy to feel proud of the products and services produced by RTI. I like the variation of my role and that I get to work with a wide variety of people across the globe. I enjoy working at RTI because it is a place that demands excellence while still allowing a healthy work-life balance." Tierra Vazquez Sr. Administrative Assistant-International Education

Senior Systems and Software Validations Specialist

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Information Technology
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Health Solutions
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180YC Requisition #
Thanks for your interest in the Senior Systems and Software Validations Specialist position. Unfortunately this position has been closed but you can search our 162 open jobs by clicking here.

 

 

 

Required Education and Experience:

  • Bachelors level degree in a scientific or life sciences discipline.
  • A minimum of 10+ years of relevant and increasingly responsible experience in the Biotech/Pharmaceutical Industry in a GCP validation, testing, and/or compliance role.
  • Demonstrated expertise of Good Clinical Practice (GCP) and knowledge of applicable Codes of Federal Regulations as they apply to computerized systems.
  • Demonstrated familiarity with IT operating systems both Microsoft and Linux based, database structure, system security and configuration.
  • Demonstrated familiarity with IT System/Software Development Life Cycle (SDLC) and validation needs and activities.
  • Demonstrated validation script writing and review experience is required, including experience supporting regulatory authority inspections. 
  • Experience with systems such as SAS, TMSWeb, and CoSign considered a plus.

 

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