Computer Systems Validation Specialist

3 weeks ago


Maple Grove, Minnesota, United States Three Point Solutions Full time
About This Role:

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.
What We're Looking For:

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
Preferred Qualifications:
  • 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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