Computer Systems Validation Specialist
3 ore fa
We are a 100% employee-owned company established in 1996, with over 700 people worldwide. Our mission is to provide exceptional consulting services to FDA regulated and other mission-critical industries.
Job DescriptionWe are seeking a skilled Computer Systems Validation (CSV) Engineer to join our team. As a CSV Engineer, you will be responsible for developing and executing protocols and test scripts, identifying gaps, and consulting on and directing plans for resolution.
Key Responsibilities:- Develop and execute protocols and test scripts
- Identify gaps and consult on plans for resolution
- Write GxP computer validation and 21 CFR Part 11 related documentation
- BS in Computer Science or Engineering field or equivalent experience
- 2-7 years' experience with Computer systems validation
- 2 years' experience working in a GMP environment
- Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired
- Opportunity to work with cutting-edge technologies in the advanced medicine space
- Collaborative culture that ensures exemplary work across our entire range of professional services
- Investment in your future, with hands-on certifications and professional training
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