Validation Engineer Consultant II

San Diego - California - United States - Life Sciences & Health Care - Medical devices - Embedded Software - Academic Bachelor

We are working with a large international medical device company to bring a validation engineer on to their team in San Diego, CA. This role is a 6 month contract with a good chance of being extended.

Feel free to contact

Daniel Hennelly, Account manager

Apply now

About this role

Expert and technical lead with proven experience. Guide and participate in test method validation, risk assessment, requirement development, protocol and validation report writing. Maintain, Validate and Release Test Systems in Production Environment, ideally in FDA regulated business. Firm understanding of IQ, OQ, PQ and Software Validation requirements and practices. Expertise in PFMEA, Gage R&R, test system and manufacturing software validation for medical devices within manufacturing environment. Ability to learn and adapt to QMS and work closely with the Engineering community on new validation methods and re-validation projects. Guide and participate in bug testing, identification, and problem solving.

About you

  • Minimum 5 - 10 years of experience in software validation of R&D, Manufacturing and large scale computer systems (e.g. HP Quality Center, SAP, Trackwise, Enovia, Windchill, DOORS, etc.);
  • Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR part 820, Part 11, ISO 13485, AAMI TIR 36, FDA Guidance, General Principles of Software Validation and GAMP 5;
  • Experience and Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections;
  • Experience in leading and educating teams on the appropriate validation documentation created as objective evidence for software validations per company procedures, standards and regulations (e.g. 21 CFR part 820, Part 11, ISO 13485, AAMI TIR 36, FDA Guidance, General Principles of Software Validation and GAMP 5);
  • Applied knowledge and understanding of (IQ) Installation Qualification, (OQ) Operational Qualification, (PQ) Performance Qualification, (UAT) User Acceptance Testing, (SAT) System Acceptance Testing;
  • Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection and notified bodies to ensure a comprehensive documentation package is created and maintained;
  • Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives;
  • Effective judgment and decision making skills, typically made under stressful situations.

Summary

  • Vacancy number: PUB191694
  • Location: San Diego
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Medical devices
  • Education level: Academic Bachelor
  • Area of Expertise: Embedded Software
  • Closing date: Thursday, February 7, 2019
Apply now

Feel free to contact

DH

Daniel Hennelly

Account manager Brunel Energy USA Houston

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