CSV & R&D Engineer – GxP Compliance & AI Tools

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

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