CSV Consultant

Remote • Posted 3 hours ago • Updated 3 hours ago
Contract W2
Contract Independent
6 Months
No Travel Required
Remote
40+
Fitment

Dice Job Match Score™

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Job Details

Skills

  • CSV engineer

Summary

Experience: 5-10 years 
CSV Consultant is responsible for validating computerized systems used in regulated industries such as pharmaceuticals, biotechnology, healthcare, and medical devices to ensure compliance with regulatory requirements (FDA, GxP, 21 CFR Part 11).
Key Responsibilities
  • Prepare and review validation documents (URS, FS, DS, IQ, OQ, PQ).
  • Perform risk assessments and validation testing.
  • Ensure compliance with FDA, GxP, and regulatory standards.
  • Support audits, inspections, and quality assurance activities.
  • Work with business, IT, and quality teams during system implementation and upgrades.
  • Manage change control, deviations, and CAPA documentation.
Required Skills
  • Experience in Computer System Validation (CSV).
  • Knowledge of GxP, FDA 21 CFR Part 11, and validation lifecycle.
  • Strong documentation and testing skills.
  • Experience with pharmaceutical, biotech, or healthcare systems.
Skills: 
Computer System Validation (CSV), GAMP 5, FDA 21 CFR Part 11, GxP Compliance, IQ/OQ/PQ, Validation Testing, Risk Assessment, CAPA, Change Control, Data Integrity (ALCOA+), SAP, Veeva Vault, TrackWise, LIMS, QMS, Audit Support, Documentation Management, Regulatory Compliance, Pharmaceutical & Life Sciences Systems Validation.
 
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: 91163703
  • Position Id: 8989206
  • Posted 3 hours ago
Contact the job poster
Avinash Kumar

Avinash Kumar

Recruiter @ Altitude Technology Solutions Inc
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