CSV Lead

Shrive Technologies LLC

2d • $45 - $50 • Remote

About The Position

The CSV Lead will be responsible for Computer System Validation within the pharmaceutical and biotechnology industries. This role requires extensive experience with LIMS systems, specifically Lab Vantage, and a deep understanding of the System Development Lifecycle in a regulated environment.

Requirements

• LIMS – Lab Vantage
• CSV (Computer System Validation)
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed