Computer Systems Validation Specialist
3 weeks ago
As a Computer Systems Validation Engineer at Three Point Solutions, you will play a critical role in ensuring the quality of our client's software applications and equipment by validating/qualifying to specifications. Your expertise in FDA regulations and electronic records/electronic signatures will be invaluable in providing comprehensive documentation to meet regulatory requirements.
Your Responsibilities Include:
- Develop comprehensive specifications for equipment/software from basic functionality to complex systems.
- Provide project estimates independently and review estimates for junior engineers.
- Submit specifications, protocols, and reports for approvals and documentation control.
- Develop and execute software validation and/or equipment qualification protocols.
- Document, communicate, and follow up on software/equipment issues.
- Complete project deliverables per project schedule and monitor project schedule and scope changes.
- Create documents, links, and Change Requests using a Product Data Management system.
- Provide information on FDA/QSR regulations and internal process validation policy.
- Develop and review comprehensive validation procedures in compliance with FDA.
- Perform project lead activities on small to large-scale validation/qualification projects.
- Provide guidance, mentoring, and training to junior engineers.
Minimum Qualifications:
- Bachelor's Degree in Engineering Discipline
- 5-9 years direct experience
- Experience in Medical Device manufacturing specifically writing compliance documentation
- In-depth knowledge of MS Office tools
- Excellent organization, clear verbal, and written skills
- Experience working in a SDLC-system development lifecycle
- Hands-on skills using navigating equipment user interfaces
- High-level attention to detail and ability to support multiple priorities at once
- Team-oriented with people skills and positive can-do attitude
- Experience working in FDA-regulated industry
- Experience working with a regulatory body in an audit
- Performed in a quality role ensuring industry compliance
- Practical knowledge of 21 CFR Part 11 (electronic records/electronic signature)
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