Validation Engineer - Katalyst Healthcares and Life Sciences : Job Details

Validation Engineer

Katalyst Healthcares and Life Sciences

Job Location : Maple Grove,MN, USA

Posted on : 2025-01-29T19:35:51Z

Job Description :
Responsibilities:
  • 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 vi Change Request.
  • Develop comprehensive software validations and/or equipment qualification protocols per the specification.
  • Execute software validation and/or qualification protocols & record results.
  • Documents 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.
  • What We're Looking For:
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).
Apply Now!
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