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Senior Systems and Software Validations Specialist

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Information Technology
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Health Solutions
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180YC Requisition #
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RTI Health Solutions(RTIHS) is looking to add a Senior Systems and Software Validations Specialist to the Systems and Software Validation team.

 

In this role, you will be tasked with performing a variety of activities as they relate to for the analysis, development, modification, installation, testing and maintenance of validated operating systems and application software. The work being performed will be conducted in a highly regulated environment, requiring experience in the pharmaceutical and/or clinical research domain(s).

 

Responsibilities will include but not be limited to:

  • Serve as validation resource for RTI-HS OQA, and Management.
  • Transition GxP requirements into validation documents and testing procedures applicable to specific systems and in the interpretation and reporting of the testing results
  • Assist the System Owner, the RTI-HS OQA, and Management in vendor evaluation.
  • Assist the System Owner with the development and execution of qualification documents, as appropriate.
  • Assist in the development of appropriate testing paradigms.
  • Assist in the resolution of system deficiencies and testing discrepancies.
  • Assist in the development and review of system SOPs as necessary.
  • Review validation documentation and denote acceptability of the system.
  • Participate in change control processes as defined in site-approved procedures.
  • Work with members of RTI ITS, as well as hosted facility engineers on oversight and management of implementations, validations, and change control of validated systems.

 

 

 

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.

 

#LI-BM1

Physical and mental demands of this role include those that must be met by an employee to successfully perform the essential functions of this job, as outlined above.  Examples include:  remaining in a stationary position for long periods of time; operating a computer and other office machinery; thinking, learning, and concentrating effectively and frequently communicating with other people, both within RTI and outside of RTI; frequently moving about inside and travel between offices and laboratories; frequently conducting laboratory site inspections (if applicable), ability to handle the stress associated in meeting frequent, multiple and tight deadlines, ability to work in excess of 40 hours per week as workload and deadlines may require, consistent demonstration of mental stability and ability to have regular, reliable and predictable attendance.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job, per RTI procedure 4.2.1. 


RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.
 
For USA Job Postings Only: RTI participates in the US Government E-Verify program. Further information regarding the E-Verify program and laws that are designed to protect you against discrimination relating to your legal right to work in the US can be found at https://www.rti.org/jobs.
 
For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.
 
We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.

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