Validation Lead

San Francisco, CA, US • Posted 3 days ago • Updated 3 days ago
Contract Independent
Contract W2
No Travel Required
On-site
Depends on Experience
Fitment

Dice Job Match Score™

👾 Reticulating splines...

Job Details

Skills

  • Computerized System Validation
  • DMS
  • QMS

Summary

Responsibilities:

  • Lead Computer System Validation (CSV) activities, including plans, protocols (IQ/OQ/PQ), reports, SOPs, and risk assessments.
  • Collaborate with business, IT, and compliance teams to define and execute validation requirements.
  • Provide oversight, training, and leadership for validation processes across regulated environments.
  • Ensure compliance with FDA, EU GMP, 21 CFR Part 11, Annex 11, and other standards.
  • Manage audits, deviations, CAPAs, and change controls.
  • Act as SME for CSV, drive process improvements, and maintain documentation quality.

Qualifications:

  • 8–10 years of CSV experience in pharma, biotech, or medical devices.
  • Strong knowledge of SDLC, GAMP 5, software QA, and industry standards (ISO, ASQ, AAMI).
  • Experience with QMS, DMS, and validation management systems.
  • Project management and leadership skills; certified auditor preferred.
  • Bachelor’s/Master’s in Computer Science, Engineering, or related field

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: 90957309
  • Position Id: 8954083
  • Posted 3 days ago
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