Job Details

  • Title: Validation Specialist
  • Code: RCI-BMS-28232-1
  • Location: Princeton New Jersey (NJ) 08543
  • Posted Date: 08/13/2019
  • Duration: 6 Months
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  Job Description

  • 6+ years’ experience
  • Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes
  • Follow SOPs and industry best practices
  • Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
  • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
  • Review validation deliverables for projects which are contracted to third party suppliers
  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
  • Assist in planning, implementing, and documenting user acceptance testing
  • 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
  • Approve validated computer system related change requests
  • Monitor regulatory and inspection trends and advise the business on suitable action
  • Ability to create documents to an existing document standard.
  • Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.
  • Advanced 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. HP 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
Must Have Skills:
  • 3-4 years' experience in computer system validation regarding GxP environment.
  • Strong skills in testing tools such as HP ALP or JIRA.
  • Experience with ServiceNow is a plus.
  • Authoring and reviewing validation deliverables a plus.
  • Strong communication skills