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Senior/Principal CSV Consultant

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Product Life Group

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Location:
United States

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Category:
Consulting

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Contract Type:
Not provided

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Salary:

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Job Description:

PLG is seeking a highly skilled Senior/Principal CSV Consultant to lead and support Computerized System Validation (CSV) and Data Integrity (DI) projects across regulated life sciences environments. This role involves hands-on execution, strategic consulting, and client-facing responsibilities, contributing to the deployment of digital quality solutions such as eQMS, eValidation, and IT governance frameworks.

Job Responsibility:

  • Lead or support validation projects, including planning, execution, and documentation of CSV deliverables
  • Conduct system testing, defect tracking, and resolution activities
  • Review and approve validation deliverables authored by junior team members
  • Collaborate with clients to gather requirements, assess compliance gaps, and define validation strategies
  • Support digital quality initiatives, including deployment of eQMS and eValidation solutions
  • Contribute to audit and inspection readiness by ensuring documentation quality and regulatory alignment
  • Provide mentoring and guidance to Associate-level consultants
  • Oversee development of IT governance SOPs and quality documentation
  • Design and lead Data Integrity programs, including risk identification and mitigation
  • Conduct project, system, and vendor audits
  • Support operational controls such as change control, configuration management, incident management, and CAPA

Requirements:

  • Bachelor’s degree or higher in a relevant field (e.g., Life Sciences, IT, Quality)
  • 2–5 years of experience in Computerized System Validation (CSV), Data Integrity (DI), or IT Quality within a regulated life sciences environment
  • Strong understanding of GxP, FDA 21 CFR Part 11, Annex 11, and other applicable regulations
  • Hands-on experience authoring and executing validation deliverables, including URS, FS, IQ, OQ, PQ
  • Hands-on experience with risk-based validation approaches, such as GAMP 5 and ASTM E2500
  • Experience with validation of systems such as LIMS, CTMS, ERP, or eQMS platforms
  • Familiarity with systems across clinical, manufacturing, laboratory, supply chain, and pharmacovigilance environments
  • Experience with eValidation tools and digital quality platforms
  • Familiarity with IT infrastructure qualification (e.g., cloud, SaaS, hosting environments)
  • Exposure to lifecycle risk management, supplier assessment, and periodic review processes
  • Experience with data integrity tools and techniques (e.g., GEMBA, gap analysis, data analytics)
  • Understanding of additional regulatory frameworks (e.g., Data Privacy, Sarbanes-Oxley)
  • Proficiency in Microsoft Office tools for documentation, reporting, and presentation
  • Experience with regulated domains, including GLP, GCP, GMP, GDP, GPvP

Additional Information:

Job Posted:
December 11, 2025

Employment Type:
Fulltime
Work Type:
Remote work
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