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KH

CSV Engineer

Katalyst Healthcares & Life Sciences
  • 🇺🇸 United States
  • Hybrid
  • Staff / Principal
  • 4 hours ago
  • GMP
  • Change Management
4 hours ago
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Summary :
We are seeking a CSV Engineer to lead Computer System Validation (CSV) compliance activities for capital and strategic projects in a regulated pharmaceutical or biotechnology environment. This role serves as the technical compliance authority for project teams, providing guidance on SDLC, CSA, qualification, and validation approaches, and authoring, reviewing, and approving validation lifecycle deliverables in line with applicable SOPs and regulatory requirements. The ideal candidate works independently across multiple projects and sites and partners closely with Quality, Engineering, Automation, and Project Delivery teams.

Roles & Responsibilities:
  • Lead CSV compliance activities for capital and strategic projects, maintaining compliance support coverage across assigned projects and sites.
  • Author, review, and approve validation lifecycle deliverables, including Quality Assurance Plans (QAPs), risk assessments, requirements, test documentation, and summary reports, in accordance with applicable SOPs and regulatory requirements such as 21 CFR Part 11, ensuring timely generation, review, and approval.
  • Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches, supporting the development of compliant validation strategies.
  • Approve SDLC documents as the technical unit and support successful execution of SDLC and validation activities across assigned projects.
  • Participate in project meetings, project governance, and CSV compliance reviews.
  • Assist with project change controls, deviations, and CSV compliance-related risk assessments.
  • Maintain project CSV compliance trackers, metrics, and reporting.
  • Track and communicate compliance risks and issues to the Global CSV Compliance Lead, working proactively to minimize project delays caused by compliance resource constraints.
  • Support SOP implementation and compliance initiatives.
  • Collaborate with Quality, Engineering, Automation, and Project Delivery teams to maintain compliance with internal procedures and applicable regulatory requirements.
Education & Experience :
  • Bachelors degree in Engineering, Science, Computer Systems, or a related discipline.
  • 7+ years of experience in Computer System Validation (CSV), CSA, and automation compliance across shopfloor, enterprise, laboratory, and quality systems within a regulated pharmaceutical or biotechnology environment.
  • Strong knowledge of GAMP 5, FDA 21 CFR Part 11, and EU GMP Annex 11.
  • Strong knowledge of risk-based validation and CSA principles and the Software Development Lifecycle (SDLC).
  • Working knowledge of change management and deviation processes.
  • Experience supportin
  • g capital projects and GMP computerized systems.
  • Strong stakeholder management and communication skills, with the ability to work independently across multiple projects and sites.

CSV Engineer · Katalyst Healthcares & Life Sciences

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