Validation Engineer, II

This role will be based in our Cambridge, MA location until our new state of the art facility located in Burlington, MA is ready Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing validation professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Validation Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve. POSITION SUMMARY Responsible for performing validation in a GMP biotech manufacturing facility. DUTIES AND RESPONSIBILITIES 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. QUALIFICATIONS, EDUCATION AND EXPERIENCE 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. 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. Must be people oriented and a team player. Experience with Microsoft Office including Excel, PowerPoint, Word, Project and Visio. Familiarity with temperature chamber, sterilization, cleaning, software and depyrogenation qualifications. Prior experience with troubleshooting, investigating and effectively documenting deviations and discrepancies on project execution. Experience with writing validation protocols, project plans and final reports and managing validation projects. Ability to read/interpret engineering drawings and design documents. Knowledge of risk management tools and techniques. Knowledge of international regulatory requirements 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. EEO Statement All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.

Created: 2024-10-19