Computer System Validation (CSV) Engineer

METRIX IT SOLUTIONS INC; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

METRIX IT SOLUTIONS INC is seeking an experienced Computer System Validation (CSV) & R&D Specialist to support validation activities for GxP-regulated systems. The role requires strong knowledge of CSV regulations, validation documentation, risk-based testing, audit readiness, and R&D collaboration.

You will work with business, IT, QA, Regulatory, and R&D teams to ensure compliant system implementations and changes, while leveraging CSA fundamentals and exposure to AI tools in regulated

Qualifications

• Core CSV knowledge and experience with GxP-regulated systems.
• Familiarity with CSA fundamentals and risk-based testing.
• Experience documenting validation activities and quality processes.
• Exposure to AI tools/applications in regulated R&D environments.
• Ability to collaborate with QA, Regulatory, IT, and R&D stakeholders.

Responsibilities

• Prepare URS, FS, validation plans and protocols.
• Review final validation reports for completeness and compliance.
• Support audit readiness, deviation investigations and CAPA activities.
• Collaborate with QA, Regulatory, IT, and R&D stakeholders to enable compliant system changes.
• Apply risk-based validation and testing aligned with CSA fundamentals.
• Maintain validation records and supporting evidence for inspections.
• Review audit trails, access rosters, and periodic validation reviews.
• Ensure compliance with 21 CFR Part 11/820, GxP, GAMP 5, SOX, and ISO standards.

Skills

Core CSV

R&D domain knowledge

GxP-regulated systems

CSA & risk-based testing

Validation documentation

RPA-based GxP bots & AI

Cross-functional collaboration

Audit readiness

Deviation investigations & CAPA

Validation reviews & compliance

Education

BSc/BA in Science/Tech/Pharmacy

Tools

Veeva Vault

Job description

Role: Computer System Validation (CSV) & R&D Specialist

Location: Delaware / Pennsylvania / New Jersey (Onsite)

Job Description

We are seeking an experienced Computer System Validation (CSV) professional with Research & Development (R&D) domain knowledge to support computer system validation activities for GxP-regulated systems. The ideal candidate will have strong knowledge of CSV regulations, validation documentation, risk-based testing, audit readiness, and R&D business functions. Exposure to AI tools and AI applications in regulated environments is a plus.

Required Knowledge, Experience & Skills

• Core Computer System Validation (CSV)
• Research & Development (R&D) domain knowledge
• GxP-regulated systems and compliance requirements
• Computer Software Assurance (CSA) and risk-based testing
• Validation documentation and quality processes
• RPA-based GxP bots and AI applications in regulated environments
• Collaborate with business, IT, Quality Assurance, Regulatory, and R&D stakeholders to support compliant system implementations and changes.
• Apply risk-based validation and testing practices aligned with Computer Software Assurance (CSA) fundamentals.
• Support audit and inspection readiness by maintaining validation records and supporting evidence.
• Support deviation investigations, CAPA activities, and compliance documentation.
• Perform periodic reviews, audit trail reviews, and access roster reviews.
• Review validation plans, protocols, specifications, and final reports for completeness and compliance.
• Ensure validation deliverables comply with applicable regulatory requirements and internal quality procedures.
• Support CSV activities across GxP systems and R&D functions.
• Understand RPA-based GxP bots and AI applications within GxP-regulated R&D environments.
• Maintain a high-level understanding of key R&D functions, including:
• Clinical
• Discovery
• Medical Affairs
• Regulatory Affairs
• Maintain a high-level understanding of the Veeva Vault suite.
• Prepare and review validation documentation, including:
• User Requirements Specifications (URS)
• Functional Specifications (FS)
• Validation plans and protocols
• Final validation reports
• Support deviation management, CAPAs, SOP compliance, and policy compliance processes.
• Support audit and inspection readiness, periodic reviews, access roster reviews, and audit trail reviews.
• Apply applicable regulatory and quality standards, including 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, and ITIL.

Qualifications

• Minimum 5 years of experience in Computer System Validation (CSV) for GxP-regulated systems.
• 8+ years of overall professional experience.
• Bachelor's degree in Science, Technology, or Pharmacy.
• Strong understanding of CSV documentation, regulatory compliance, risk-based testing, and quality management processes.
• Experience working with cross-functional stakeholders in regulated R&D environments.
• Exposure to AI tools and AI applications is a plus, particularly in GxP-regulated environments.