CSV Engineer

CSV Engineer / Validation Engineer (Hybrid)

Role Overview

As a CSV Engineer, you will identify and implement industry best practices using an extensive industry network and detailed knowledge of applicable regulations. You will collaborate with experienced CSV team members during project scoping to identify roadblocks and drive efficiencies across site and process improvement projects.

Key Responsibilities

• Project Leadership: Execute all responsibilities as the CSV owner for significant site and process improvement projects, ensuring compliance with regulatory requirements and industry standards.
• Quality Management (QMS): Perform all aspects of QMS processes, including Change Control, Deviations, and CAPAs.
• System Focus: Manage Change Control specifically associated with DCS (DeltaV) and MES (Syncade) systems.
• Daily Operations: * Perform risk assessments on systems.
• Review change requests and test scripts.
• Draft validation protocols.
• Initiate and review GMP documentation revisions.
• Continuous Improvement: Identify and implement industry best practices while maximizing process efficiency.
  

Key Requirements

• Validation Expertise: Substantial experience in equipment and/or computer system validation (CSV).
• Technical Systems: Working experience with Controls Automation, Process Control Systems (PCS), Distributed Systems, and Manufacturing Execution Systems (MES) is required. DeltaV experience is preferred.
• Industry Experience: Prior experience leading projects within the Biotech, Pharma, or Biologics industries.
• Core Skills: Strong attention to detail with the ability to work independently, manage deadlines successfully, and navigate complex regulations.