Contract: Verification & Validation Engineer - Senior / USAClick here to shortlist this job 1-CLICK Apply With Employer or Register Now
|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>
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.