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Skills
Biologyunmatched
Biostatisticsunmatched
Clinical Practices/Protocolsunmatched
Code of Federal Regulationsunmatched
Computer Skillsunmatched
Computer Softwareunmatched
Computer Systemsunmatched
Consultingunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
GxPunmatched
ISO 9001unmatched
ITIL (IT Infrastructure Library)unmatched
Laboratory Information Management System (LIMS)unmatched
Laboratory Notebookunmatched
Labwareunmatched
Manufacturing Requirementsunmatched
Medical Affairsunmatched
Pharmacovigilanceunmatched
Regulationsunmatched
Riskunmatched
SAPunmatched
Sarbanes-Oxley Act (SOX)unmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Systems Engineeringunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
Description
Job Summary:
Experienced CSV (Computer System Validation) Consultant with expertise in GxP-compliant environments to support validation, compliance, and audit readiness across life sciences systems.
Strong experience in CSV processes, regulatory frameworks, validation documentation, and exposure to clinical and regulatory domains.
Roles & Responsibilities:
Perform Computer System Validation (CSV) activities aligned with 21 CFR Part 11 / 820, GxP, GAMP 5, SOX, EU Annex 11 / Annex 22, ISO 9001, and ITIL.
Ensure audit and inspection readiness.
Conduct periodic reviews, access roster reviews, and audit trail reviews.
Manage deviations, CAPA processes, SOP, and policy compliance.
Author and review URS / FS documents, validation protocols, validation plans & reports, and final summary reports.
Perform risk-based validation and testing aligned with CSA (Computer Software Assurance).
Support validation lifecycle from planning to execution and closure.
Work with platforms such as Veeva Vault Suite, LabWare LIMS, SAP (GxP modules), and BIOVIA Electronic Lab Notebook.
Collaborate with teams across Biostatistics, Clinical & Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, Manufacturing, Quality, and TechOps.
Education & Experience:
8–10 years of experience in Computer System Validation (CSV).
Strong knowledge of GxP regulations, validation frameworks, GAMP 5, and CSA principles.
Experience with CAPA, deviation management, SOP, and policy compliance.
Strong documentation and validation lifecycle experience.
Good understanding of life sciences domain processes.