Validation Engineer

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profile Job Location:

Chicago, IL - USA

profile Monthly Salary: Not Disclosed
Posted on: 6 hours ago
Vacancies: 1 Vacancy

Job Summary

Position : Validation Engineer

Location : Illinois

Job description:

Apply knowledge of cGXPs relevant SOP curriculum routine project procedures project management and other trainings as appropriate.
Serve as project lead with projects of intermediate scope and cross-functional teams.
Apply knowledge of FDA21CFR Part11 GAMP5 and data integrity to analytical instrument validation.
Develop the following of FDA 21CFR part11 GAMP5 and Data integrity to analytical instrument validation
Develop the following validation deliverables - Risk management Reports change controls regulatory assessments 21CFR Part11 Assessments validation plans qualification reports and other related documents required per SOP
Responsible for the management and archiving of approved package documents
Mentors and provides leadership to junior team members
Handle routine tasks timely and accurately.

Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development Projects Requirements Analysis Software Design Software Implementation Efficient Build Release Process and turnkey software V & V Services. We have more than 20 years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment connected vehicles Cyber security OTA and Advanced Safety/ Body electronics.

Position : Validation Engineer Location : Illinois Job description: Apply knowledge of cGXPs relevant SOP curriculum routine project procedures project management and other trainings as appropriate. Serve as project lead with projects of intermediate scope and cross-functional teams. ...
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Key Skills

  • Python
  • SOC
  • Debugging
  • C/C++
  • FDA Regulations
  • Minitab
  • Technical Writing
  • GAMP
  • OS Kernels
  • Perl
  • cGMP
  • Manufacturing