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 Brook@warmanobrien.com

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