CSV Lead

PRIMUS Global Services, Inc
Raritan, NJ, United States
2 months ago
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Role details

Contract type
Permanent contract
Employment type
Full-time (> 32 hours)
Experience level
Expert
Working hours
Regular working hours
Job source

Tech stack

Automation of Tests Laboratory Information Management Systems Requirements Management System Testing GXP

Requirements

We have an immediate need for an experienced CSV Lead with strong expertise in LIMS LabVantage, Computer System Validation (CSV), GxP standards, and risk-based validation to lead validation activities within a regulated Pharmaceutical or Biotechnology environment. This is a hybrid position based in Raritan, NJ for a candidate with deep experience in LIMS LabVantage, CSV, FDA/GxP regulated environments, GAMP, validation planning, requirements documentation, compliance/validation plans, test protocols, test summary reports, validation reports, Traceability Matrix, Design Specifications, System Testing, User Acceptance Testing (UAT), automated test scripts, QA methodologies, and test procedures. No subcontracting is permitted on this position. Candidates must be willing to work directly on our payroll.

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