Computer Systems Validation Engineer

4 weeks ago

Maple Grove, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • To ensure the quality of our client's software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) per the division's policy to meet FDA regulations.
  • Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLC's, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signatures.
  • Provide project estimates independently. Review estimates for Engineer I's.
  • Submit specification, protocol and report for approvals and documentation control via a Change Request.
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Document communicate and follow-up on software/equipment issues.
  • Complete project deliverables per project schedule and monitor project schedule and scope changes to assure team can meet delivery requirements.
  • Create documents, links and Change Requests utilizing a Product Data Management system.
  • Provide information on FDA/QSR regulations and internal process validation policy with regards to software validations, equipment installation qualifications, electronic records & signatures.
  • Develop and review comprehensive validation procedures in compliance with FDA.
  • Perform project lead activities on small to large-scale validation/qualification projects. Participate in vendor evaluations.
  • Provide guidance, mentoring and training to Engineer I's & II's.
  • Ensure consistency of work among Engineer I's & II's.
  • Provide peer reviews on specifications, protocols and reports.
  • Influences and defines functional, departmental and divisional policies & procedures through involvement with cross-functional engineering initiatives.
  • Provide leadership role on championing functional best practices.

Requirements:

  • 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
  • Must have excellent organization, clear verbal and written skills
  • Experience working in a SDLC-system development lifecycle
  • Hand on skills using navigating equipment user interfaces
  • High level attention to detail and ability to support multiple priorities at once
  • Must be team-oriented with people skills and positive can-do attitude in dealing with many customers, from various departments (Engineering, R&D, Manufacturing, Regulatory, etc.)
  • 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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