CSV Lead

Shrive Technologies LLC; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Shrive Technologies LLC seeks a CSV Lead for a remote-friendly role near Raritan, NJ, with a hybrid option. The candidate will lead LIMS validation projects using LabVantage and CSV methodologies within FDA or global regulated environments.

Responsibilities include developing validation deliverables, reviewing tests and design specs, and ensuring GxP compliance and risk-based validation throughout the lifecycle. Experience with FDA guidance and GMP standards is required.

Qualifications

• Experience with CSV validation in regulated environments.
• Knowledge of GxP standards and risk-based validation.
• Familiarity with FDA guidance documents and industry standards.

Responsibilities

• Lead LIMS LabVantage validation projects in a regulated environment.
• Develop and review validation deliverables (validation plans, test protocols, test reports).
• Review system test scripts, traceability matrices, and design specs.
• Ensure QA methodologies and UAT processes align with GxP requirements.

Skills

CSV validation

GxP validation

FDA guidance

CSV lifecycle

Tools

LabVantage LIMS

Job description

Job Title - CSV Lead

Location - Raritan, NJ(Remote is fine, Hybrid preferred)

Must Have - LIMS – Lab Vantage & CSV

Key Responsibilities:

• Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs. Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.

This is a remote position.