Validation Specialist

Company: Experis
Location: Princeton
Posted on: March 18, 2023

Job Description:

Validation Specialist - Our client in (Princeton, NJ) is looking for hardworking, motivated talent to join their team. (Validation) Don't wait--- apply today! What's in it for you?

• Hybrid - Onsite as well as Remote
• Contract or Permanent
• Full time or Part Time
• (Add 1-2 other key selling points Ex: Opportunity for growth, on public transportation, etc.)Job DescriptionLocation: Princeton, NJ (Nassau Park). The candidate must be able to work onsite 50% of the time at Nassau Park, Need localsDuration: 4 months with the possibility of extension/conversionCandidates Must Be Fully VaccinatedMust-Have Requirements:
  • 2+ years of experience in managing the projects as CSV specialist /lead
  • 2+ years of experience in testing , (script reviewing from a QA perspective in particular )
  • 2+ years of experience in authoring , reviewing various validation documentation such as (Val plan , Risk assessments etc.)
  • Good communication and writing skills
  • Data Integrity experience is a plusSkills:
    • Application lifecycle management (ALM) Software: 3-5 yrs
    • Change Management: 0-2 yrs
    • Computer System Validation: 3-5 yrs
    • CSV: 3-5 yrs
    • 2+ 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 testingReview 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 structureWhy should you choose:
        • Medical, Dental, Vision, 401k
        • Weekly pay with direct deposit
        • Consultant Care support
        • Free Training to upgrade your skills
        • Dedicated Career Partner to help you achieve your career goalsAre you Interested? Share this job with friends and family and earn dollars with every successful hire.

Keywords: Experis, Trenton , Validation Specialist, Other , Princeton, New Jersey