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Validation Engineer, II

4 weeks ago

Cambridge, Massachusetts, United States Vericel Corporation Full time
Job Summary

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, seeks a skilled Validation Engineer, II to join our team in Cambridge, MA. As a key member of our validation team, you will be responsible for performing validation in a GMP biotech manufacturing facility.

Key Responsibilities
  • Develop and publish new validation project plans and protocols, execute protocols, and write final reports with minimal supervision.
  • Participate in equipment failure investigations, corrective/preventive actions, and equipment release, providing final approval for equipment release.
  • Provide technical assistance to less experienced technicians/specialists and maintain effective communication with immediate supervisors and other personnel within the group.
  • Review and approve validation and calibration documentation.
Requirements
  • Bachelor's Degree or equivalent and 4+ years of validation experience, or Master's Degree or equivalent and 2+ years of validation experience.
  • 3+ years of experience with process, equipment, utility, and/or software validation in a GMP regulated environment.
Preferred Qualifications
  • Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
  • Working knowledge of GMPs, excellent technical writing and verbal communication skills, and basic math and statistical skills.
  • Must be people-oriented and a team player, with experience with Microsoft Office, including Excel, PowerPoint, Word, Project, and Visio.