ASCII Group LLC
ASCII Group LLC

Computer System Validation - GxP/R&D

Wilmington, DE, US • Posted 5 hours ago • Updated 3 hours ago
Full Time
No Travel Required
On-site
Depends on Experience
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Life Sciences
  • Computerized System Validation
  • Corrective And Preventive Action
  • ITIL
  • Auditing
  • Identity Management
  • Management
  • Pharmaceutics
  • Regulatory Affairs
  • Biostatistics
  • Documentation
  • Research and Development
  • GxP
  • ISO 9000
  • Inspection
  • Regulatory Compliance
  • GAMP
  • Risk Assessment
  • Risk-based Testing
  • Robotic Process Automation
  • Sarbanes-Oxley
  • Artificial Intelligence
  • URS
  • Veeva
  • Testing

Summary

Hi ,
The following requirement is open with our client.
Title                                        : Computer System Validation - GxP/R&D
Location                               : Wilmington, DE (Onsite)
Duration                               : 6+ Months
Relevant Experience (in Yrs.): 8+
Looking for only W2/C2C

Job Description
We are seeking an experienced Senior Computer System Validation (CSV) Specialist with 8+ years of overall experience, including at least 5 years of hands-on experience validating GxP-regulated computer systems. The ideal candidate will have strong expertise in regulatory compliance, risk-based validation, validation lifecycle documentation, audit readiness, and quality processes, along with an understanding of pharmaceutical and life sciences R&D systems.
Key Responsibilities
  • Execute and support end-to-end CSV activities for GxP-regulated systems in compliance with applicable regulatory requirements.
  • Prepare, review, and maintain validation documentation, including URS, Functional Specifications (FS), validation plans, test protocols, execution evidence, and final validation reports.
  • Apply risk-based testing and Computer Software Assurance (CSA) principles to validation activities.
  • Support audit and inspection readiness, periodic reviews, access roster reviews, and audit trail reviews.
  • Manage deviations, CAPAs, validation issues, and compliance documentation in accordance with established SOPs and quality policies.
  • Support validation and compliance activities for R&D applications, including clinical, regulatory, pharmacovigilance, and medical affairs systems.
  • Contribute to compliance assessments for Veeva Vault applications, RPA-based GxP bots, and AI-enabled solutions in regulated R&D environments.
 
Required Skills
  • Strong knowledge of GxP regulations, 21 CFR Part 11/820, GAMP 5, EU Annex 11, SOX, ISO 9001, and ITIL.
  • Hands-on experience in Computer System Validation for GxP-regulated systems.
  • Expertise in validation lifecycle documentation, including URS, FS, validation plans, test protocols, and final reports.
  • Experience with risk assessments, risk-based testing, and CSA fundamentals.
  • Knowledge of audit readiness, periodic reviews, access management, audit trail reviews, deviations, and CAPA management.
  • Understanding of pharmaceutical and life sciences R&D processes, including Clinical, Biostatistics, Discovery, Medical Affairs, Pharmacovigilance, and Regulatory Affairs.
  • High-level understanding of Veeva Vault applications and emerging GxP technologies, including RPA bots and AI-enabled solutions.
 
MUST-HAVE SKILLS
  • GxP Computer System Validation (CSV)
  • 21 CFR Part 11 / GAMP 5
  • CSV Documentation
  • Risk-Based Testing / CSA
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10117479
  • Position Id: 9126797
  • Posted 5 hours ago
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Arun Potula

Arun Potula

IT Recruiter @ ASCII Group LLC

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