Job Details

  • Title: Validation Specialist
  • Code: RCI-36746-1
  • Location: Princeton New Jersey (NJ) 08543
  • Posted Date: 04/07/2021
  • Duration: 12 Months

  Job Description

The candidate must be able to work onsite once the WFH policy is lifted, so local is preferred. Those not local will be considered if they are willing to relocate at their own expense.

This is a Computer System Validation position. This is not for equipment or instrument validation. Candidate should have experience in CSV. This is also not a testing position.

  • Candidate is expected to perform quality review of CSV deliverables, guide application teams through the validation process.

Must Have List for Intermediate Level Validation Specialist:

  • Good communication skills
  • 3-5 years of CSV lead experience
  • 3-5 years of HP ALM
  • 3-5 years of CSV Documentation author and review
  • 3-5 years of experience in Change Control
  • Should be able to work with minimal supervision
Responsibilities
  • 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
Qualifications
  • 3-5 years of CSV lead experience
  • 3-5 years of HP ALM
  • 3-5 years of CSV Documentation author and review
  • 3-5 years of experience in Change Control
  • 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); application development and lifecycle management (e.g. HP ALM, JIRA); and IT service management systems (e.g. ServiceNow, SAP Solution Manager)
  • 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.
  • 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