CSV Lead (Computer System Validation Lead) - Only W2

Remote • Posted 2 hours ago • Updated 2 hours ago
Full Time
No Travel Required
Remote
$40 - $45/hr
Fitment

Dice Job Match Score™

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Job Details

Skills

  • GxP
  • IQ
  • Life Sciences
  • Risk Assessment
  • Stakeholder Management
  • Computer system validation

Summary

CSV Lead (Computer System Validation Lead)
The CSV Lead will be responsible for leading and managing Computer System Validation (CSV) activities to ensure compliance with regulatory requirements and company quality standards. This role involves developing validation strategies, reviewing validation deliverables, coordinating testing activities, and ensuring validated systems support business and compliance objectives. The candidate will collaborate with cross-functional teams including Quality Assurance, IT, Business, and Compliance stakeholders to drive successful validation efforts.
Primary Skill: Solution Validation
Key Responsibilities:
• Lead end-to-end Computer System Validation (CSV) activities for GxP-regulated systems.
• Develop and review validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.
• Ensure compliance with FDA, GxP, 21 CFR Part 11, and other applicable regulatory requirements.
• Coordinate testing, defect management, and validation execution activities.
• Perform solution validation and assess system changes for validation impact.
• Collaborate with business, quality, and technical teams to ensure successful project delivery.
• Support audits, inspections, and regulatory assessments related to validated systems.
Preferred Qualifications:
• Experience in CSV within pharmaceutical, biotech, medical device, or life sciences environments.
• Strong understanding of GxP regulations and validation methodologies.
• Excellent stakeholder management, documentation, and leadership skills.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 10309076
  • Position Id: 9003202
  • Posted 2 hours ago
Contact the job poster
Sumit Gupta

Sumit Gupta

Recruiter @ Nasscomm, Inc.
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