What are the responsibilities and job description for the Computer System Validation (CSV) Engineer position at METRIX IT SOLUTIONS INC?
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
- Veeva Vault suite awareness
- RPA-based GxP bots and AI applications in regulated environments
Roles & Responsibilities
- 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:
- Biostatistics
- Clinical
- Discovery
- Medical Affairs
- Pharmacovigilance
- 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.