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
Job Tags
Hourly pay, Contract work, Freelance,