Computer System Validation Engineer

Katalyst CRO; New Wilmington (Lawrence County); On-site; USD 110,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking an Experienced CSV Consultant to support validation, compliance, and audit readiness across life sciences systems in the United States. The role spans planning through closure, ensuring GxP alignment and regulatory readiness.

Candidate will work with Veeva Vault Suite, LabWare LIMS, SAP GxP modules, and BIOVIA ELN, collaborating across Biostatistics, Regulatory Affairs, Manufacturing, and Quality to ensure robust validation artifacts and audit readiness.

Qualifications

• 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.

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.

Skills

CSV validation

GxP compliance

Regulatory frameworks

Documentation

Tools

Veeva Vault Suite

LabWare LIMS

SAP (GxP modules)

BIOVIA Electronic Lab Notebook

Job description

• 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.
• 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.

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.