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.

Responsibilities:

• 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.

Required Qualifications:

• Education: Bachelor’s degree or higher in a relevant field (e.g., Life Sciences, IT, Quality).
• Experience: 2–5 years of experience in Computerized System Validation (CSV), Data Integrity (DI), or IT Quality within a regulated life sciences environment.
• Regulatory Knowledge: Strong understanding of GxP, FDA 21 CFR Part 11, Annex 11, and other applicable regulations.
• Validation Expertise:
  • 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.
• Systems Knowledge:
  • 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.
• Infrastructure Qualification: Familiarity with IT infrastructure qualification (e.g., cloud, SaaS, hosting environments).
• Lifecycle & Governance:
  • 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).
• Documentation Tools: Proficiency in Microsoft Office tools for documentation, reporting, and presentation.
• Domain Experience: Experience with regulated domains including GLP, GCP, GMP, GDP, GPvP.