Validation Engineer 3:
Akraya - sunnyvale, CA
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Primary Skills: FDA Regulations, cGMP, Protocol Development, Validation Engineering, Medical Devices Background Contract Type: W2 Duration: 6+ Months Location: Sunnyvale, CA (Hybrid) Pay Range: $65 - $70/hour JOB SUMMARY: We are seeking a highly skilled and experienced Validation Engineer for a remote 6-month position, with proficiency in Medical Device or FDA Regulated industry practices. The role involves developing and approving validation plans, performing tests, documenting results, and ensuring compliance with relevant standards. Ideal candidates should be able to handle multiple projects, meet deadlines, and adapt to changing priorities efficiently. JOB RESPONSIBILITIES: Development and approval of Validation Plans, IQ, OQ Protocols, Trace Matrices, and Risk Assessments. Analyzing business processes to translate development documents into user requirements and functional design specifications. Establishing validation standards, developing testing protocols, documenting test results, and maintaining validation records. Documenting and remediating deviations from validations/qualifications. Supporting regulatory agency inspections/audits and authoring Operating Procedures and Policies. JOB REQUIREMENTS: Bachelor's degree in a related field with at least five years of experience in a Medical Device or FDA Regulated industry. Strong knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, and ISO standards. Excellent written and oral communication skills with the ability to develop clear, concise, and timely reports. ABOUT AKRAYA Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Inc's Best Workplaces 2024 and Silicon Valley's Best Places to Work by the San Francisco Business Journal (2024) and Glassdoor's Best Places to Work (2023 & 2022)! Industry Leaders in IT Staffing As staffing solutions providers for Fortune 100 companies, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires! Join Akraya Today! Let us lead you to your dream career and experience the Akraya difference. Browse our open positions and join our team!
Created: 2024-09-16