Senior Validation Engineer Job at Warman O'Brien, Alameda County, CA

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  • Warman O'Brien
  • Alameda County, CA

Job Description

Senior validation engineer

Computer software validation - Diagnostics / Medical Device / Pharmaceutical

Contract details:

  • 12-month freelance contract
  • Onsite in California
  • 40 hours/week, competitive hourly rate
  • Global Engineering Consulting firm

Overview:

Seeking an experienced SQA professional to ensure compliance and quality of SDLC deliverables for regulated IT applications.

Responsibilities:

  • Review/approve SDLC deliverables: MVP testing, FMEA, IQ, OQ, PQ, trace matrices, system releases.
  • Provide validation expertise for IT applications and ensure compliance readiness.
  • Collaborate with development teams to align deliverables with business and compliance standards.
  • Oversee CAPAs, change controls, and defect management.

Qualifications:

  • 5+ years in software validation and QA.
  • Direct experience in medical devices/diagnostics preferred - open to pharmaceutical experience
  • Proficient in GxP regulations, validation principles, and automated testing.
  • Experience with Salesforce, Veeva, and tools like JIRA, Tosca, ALM, and Confluence.
  • Knowledge of Agile and Waterfall methodologies.

Please apply direct or share a copy of your resume to [email protected]

Job Tags

Hourly pay, Contract work, Freelance,

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