Senior/Principal CSV Consultant Jobs

Product Life Group

Location:
United States

Category:
Consulting

Contract Type:
Not provided

Salary:

Not provided

Save Job

Apply Position

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

View All Jobs In This Company

Job Link Share:

Senior/Principal CSV Consultant