CSV Engineer

Raritan, NJ, US • Posted 30+ days ago • Updated 9 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

🔗 Matching skills to job...

Job Details

Skills

  • Inventory
  • Test Plans
  • Scripting
  • Regulatory Compliance
  • Leadership
  • Collaboration
  • Pharmaceutics
  • Medical Devices
  • Computerized System Validation
  • Enterprise Resource Planning
  • Data Migration
  • Cloud Computing
  • Migration
  • Acquisition
  • GxP
  • Documentation
  • URS
  • IQ
  • OQ
  • PQ
  • Acceptance Testing
  • Traceability Matrix
  • Test Methods
  • Management

Summary

Roles & Responsibilities
  • Lead end-to-end CSV activities (inventory assessment remediation disposition)
  • Support business separation for large GxP systems
  • Define & implement risk-based validation strategies
  • Review & approve test plans, UAT scripts, validation documents
  • Ensure compliance with regulatory & quality standards
  • Provide guidance, escalation & leadership to validation teams
  • Collaborate with global & remote teams
Education & Experience :
  • 7-10 years in CSV / Validation roles
  • Experience in Pharma / Biotech / Medical Devices industry
  • Proven experience in regulated environments (FDA/GxP)
  • Strong expertise in CSV (Computer System Validation) in GxP environments
  • Experience in ERP, Data Migration & Cloud Migration (Divestiture/Separation)
  • Hands-on in Acquisitions / Divestitures / Business Separation projects
  • Deep understanding of FDA regulations & GxP standards
  • Experience with Risk-based validation approach
  • Strong knowledge of validation documentation (VP, URS, IQ/OQ/PQ, TSR, SOPs)
  • Experience in UAT, Traceability Matrix & QA methodologies
  • bility to lead teams & manage multiple projects
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: 91116760
  • Position Id: 581401294838ed93edbcff2023f0e4c9
  • Posted 30+ days ago
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