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Validation Engineer
2 months ago
We are seeking a highly skilled and experienced Validation Engineer to join our team for a 6-month remote position. The ideal candidate will have proficiency in Medical Device or FDA Regulated industry practices.
Job Summary:The role involves developing and approving validation plans, performing tests, documenting results, and ensuring compliance with relevant standards. The successful candidate will be able to handle multiple projects, meet deadlines, and adapt to changing priorities efficiently.
Key Responsibilities:- Develop and approve validation plans, IQ, OQ protocols, trace matrices, and risk assessments.
- Analyze business processes to translate development documents into user requirements and functional design specifications.
- Establish validation standards, develop testing protocols, document test results, and maintain validation records.
- Document and remediate deviations from validations/qualifications.
- Support regulatory agency inspections/audits and author operating procedures and policies.
The successful candidate will have a 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 is required. Excellent written and oral communication skills are essential.
About Akraya:Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. We are industry leaders in IT staffing, providing staffing solutions for Fortune 100 companies. We don't just connect you with great jobs, we connect you with a workplace that inspires.
