Contract: Verification & Validation Engineer - Senior / USA

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:

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.