Validation Engineer – FILLED

The Wellington Group has been engaged to find a Validation Engineer with 5 to 10 years experience as a project manager (PM) for processes, equipment, CSV, and methods validation. Exciting new opportunity with a very innovative, health-science, devices based company. Who Do You Know?

This position is responsible for responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program. Will provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities, work with the CAPA team and participate as an active member on new product development teams.

The qualified candidate will have:

  • BS or higher level of degree in engineering or science
  • 5+ years experience with companywide validation needs, 10 years is ideal in medical devices or other FDA regulated industry
  • Experience developing and executing IQ, OQ and PQ protocols for product, processes, facilities, software, cleaning and equipment
  • Strong FDA, cGMP and ISO knowledge and quality program management
  • Must have project management experience (PM)
  • Experience and knowledge in continuous improvement methods required
  • Knowledge and ability with FMEA and risk analysis
  • Ability to read and understand blue prints and technical drawings
  • Strong communications skills both written and oral
  • Experience with SPC, CAPA, DOE is a plus
  • High level of proficiency with MS Office, Minitab, and working with databases

Industry: Validation, IQ, OQ, PQ, Engineering, equipment, cleaning, methods validation, quality systems, San Diego, CAPA, FMEA, Risk Analysis, ISO, Continuous Improvement,  medical device, IVD, project management, PM

Job Code: 411-32-MH2322

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( 910-338-2795

jobs filled