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Principal Validation Engineer

2 months ago

Cleveland, United States BioTalent Full time

The Role:

Our client, a world-renowned medical device manufacturer, is looking for a Principal Validation Engineer for their growing team in Cleveland, MS.



Must Haves:

  • BS degree required. (Engineering, Computer Science or other Science Field)
  • 3 years or more minimum related experience.
  • Experience with Wonderware, Allen-Bradley PLC/HMI, Access, Microsoft Project preferred.
  • Basic knowledge of manufacturing processes and the ability to quickly learn and understand processes/applications.
  • ASQ Certification (CQE or CSQE) or equivalent desired.



Responsibilities:

  • Preform equipment qualification, test method and process validation activities, process capability and process control studies for assigned areas.
  • Plan and implement software validation activities in manufacturing and support areas.
  • Drive quality/manufacturing projects applying Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.
  • Support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technologies.
  • Lead process improvement projects including automation and computerization.
  • Ensure computer systems and applications are aligned with regulatory quality standards through validation activities.
  • Responsible for ensuring FDA regulations are met for system upgrades/replacements.
  • Responsible for audits, creation, and implementation of Specifications/SOPs.
  • Responsible for ensuring the quality of facility systems (validation):
  • Writing and implementing protocols and test cases for validations.


On Offer:

  • 4 Weeks PTO
  • Relocation Assistance
  • 401K Match
  • Employee Stock Purchase Program
  • Paid Parental Leave
  • Medical, Dental and Vision
  • Tuition Reimbursement



***NO C2C