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Validation Engineer

2 months ago

Cambridge, Massachusetts, United States Vericel Corporation Full time
Job Title: Validation Engineer

Vericel Corporation is seeking a highly skilled Validation Engineer 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 execute validation project plans and protocols.
  • Participate in equipment failure investigations and provide final approval for equipment release.
  • Provide technical assistance to less experienced technicians/specialists.
  • Review and approve validation and calibration documentation.
Requirements:
  • Bachelor's Degree or equivalent and 4+ years of validation experience.
  • 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.
  • Basic math and statistical skills.
Working Conditions and Physical Demands:
  • May be required to work in classified and controlled areas such as clean room environment wearing special garments.
  • May be required to lift, push or pull up to 40 lbs.

Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. We are committed to diversity and inclusion in the workplace.