CSV Lead

Job Title: CSV Lead Location - Remote Mandatory Skills - LIMS Lab Vantage & CSV Job Summary: 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 guidances and industry standards (i.e., GAMP)Experience in writing and executing documentation for all aspects of the validation deli

Role: Validation Lead Location: Raritan, NJ(Hybrid) Duration: 6+ Months Job Description: Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment

Role: LabVantage LIMS - Lead Engineer Location: Remote USA Duration: 12+ months Role and responsibilities: We are seeking a highly experienced Lead LIMS Engineer with deep expertise in LabVantage LIMS to lead the design, implementation, enhancement, integration, and support of enterprise laboratory information management solutions within a regulated Life Sciences environment. The ideal candidate will serve as a technical leader responsible for driving LIMS strategy, solution architecture, plat

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.