Validation Specialist

New Brunswick, New Jersey

 Katalyst Healthcares and Life Sciences
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Roles & Responsibilities
  • Review computerized systems validation documents such as: Requirements Specification, Design Specification, CSV Risk Assessment, Test Plans, Test Summary Reports, Data Migration Plan, Pre/Post Executed Test Scripts, Traceability Matrix.
  • Release to Production Statements Direct and review testing Provide guidance on quality issues that affect the integrity of the data, or the system Obtain and respond to QA review.
  • Participate in establishing standard quality and validation practices Independently assess compliance practices and recommend corrective actions.
  • pprove validated computer system related change requests Monitor regulatory and inspection trends and advise the business on suitable action.
  • bility to create documents to an existing document standard.
  • ble to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
  • dvanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
  • Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc).
  • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
  • Once trained, have the ability to work independently on CSV projects with minimal oversight. Ability to perform in a highly matrixed organization structure.
Date Posted: 26 May 2025
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