Compute System Validation(CSV) with R&D

TechClub Inc; Wilmington (DE); On-site; USD 140,000 - 190,000; Full time

Job summary

TechClub Inc in Wilmington, Delaware is seeking a Compute System Validation (CSV) professional with strong R&D knowledge to join an on-site team. The role focuses on validating GxP software and ensuring regulatory compliance in a fast-paced environment.

The candidate should have 8+ years of overall experience, including 5+ years in CSV for GxP systems, and be proficient with Veeva Vault and risk-based testing to support audits and inspections.

Qualifications

• Bachelor's degree in Science/Technology or Pharmacy.
• 8+ years overall experience with at least 5 years in C(S)V for GxP systems.
• Strong knowledge of regulatory standards and GxP frameworks.

Responsibilities

• Author and maintain CSV validation plans and final reports.
• Perform risk-based testing aligned to CSA fundamentals.
• Ensure audit readiness and proper document control.

Skills

CSV standards & compliance

URS/FS authoring

Veeva Vault familiarity

Risk-based testing

Education

Bachelor's degree in Science/Technology/Pharmacy

Tools

Veeva Vault

Job description

Role: Compute System Validation(CSV) with R&D Knowledge

Location: Wilmington, DE

(100% onsite Role)

Job Description

Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor’s in Pharmacy

Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system

Knowledge, Experience And Skills

{

CORE CSV

• 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
• Authoring of URS/FS, protocols, final reports, validation plan/report
• High-level understanding of Veeva Vault suits
• Risk-based testing aligned to CSA fundamentals

}

AND

{

R&D

• High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

}