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Contract: Verification & Validation Engineer - Senior / USA

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Location: Loveland, Colorado, USA
Salary:USD400 - USD480 per day

The client is seeking an engineering rock-star for a multinational medical d evice company located in Loveland, CO. The ideal candidate will have a C hemical/Biomedical engineering background and experience in validating p rocesses within a regulated industry.

The Verification & Validation E ngineer will review and analyze electrical, mechanical, software and chemistry s pecifications to identify critical parameters; write validation protocols that c hallenge the critical parameters related to the installation, operation and p erformance of the related manufacturing process, software or equipment; e xecute validation protocols based on SOP's; assure acceptability of test data; a nalyze and gather test data in compliance with cGMP and safety r equirements, as well as adherence to internal company policies and p rocedures.

Job Responsibilities:

< ul>
  • Work with development team to develop test protocols to verify s ystem's ability to meet requirements and characterize system across ranges of p erformance specifications. Execute test protocols at the system and s ubsystem levels
  • Analyze data and create test reports.
  • < li>Perform root cause investigations for testing failures.
  • Perform i mpact analysis on design changes and propose regressions tests needed to e nsure performance.
  • Job Qualifications: < /p>

    • Bachelor's degree in Chemical, Mechanical or Biomedical E ngineering or other similar baccalaureate degree and 6 years of relevant e xperience
    • or Master's degree(s) and 4 years of relevant e xperience
    • or PhD and 2 years of relevant experience

    < strong>Candidate Skills needed:

    • 6 or more years of e xperience in process validation within a regulated industry
    • Good u nderstanding of validation methodologies
    • Able to evaluate system s pecifications and requirements for completeness and testability
    • Able t o generate test protocols and procedures from specifications
    • Able to e xecute test procedures manually, with minimal guidance
    • Must have g ood written and oral communication skills
    • Experience in Statistics / E ngineering Analysis
    • Experience with FDA or other Regulated Process i s highly desirable.

    How to Apply

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