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Vericel Corporation Validation Engineer, II in Cambridge, Massachusetts

Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Medical Affairs professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. POSITION SUMMARY Responsible for performing validation in a GMP biotech manufacturing facility. DUTIES Essential Functions: Master core responsibilities of an Engineer, Validation, I. Develop and publish new validation project plans and protocols, execute protocols and write final reports with little to no supervision. Participate in equipment failure investigations, corrective/preventive actions and equipment release. Provide final approval for equipment release. Provide technical assistance to less experienced technicians/specialists. Routine and effective communication with immediate supervisor and other personnel within the group in addition to outside the department. Review and approve validation and calibration documentation. Other duties as assigned. Basic Qualifications: 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 experienced with process, equipment, utility, and/or software validation in a GMP regulated environment. WORKING CONDITIONS AND PHYSICAL DEMANDS May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements. May be required to lift, push or pull up to 40 lbs.

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