Sr. Validation Engineer

Job Description

Job Description

At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).

Position Summary :

The Senior Validation Engineer will be responsible for performing validation in a GMP biotech manufacturing facility.

Schedule :

This position is in-office Monday-Friday in our Cambridge, MA location.

Position Scope :

• Perform validation activities in the media preparation, cell culture, utilities and QC areas of a cGMP biotech manufacturing facility.
• Perform hands on execution of installation, operational and performance qualifications for equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing processes in accordance with predefined test protocols.
• Develop and publish new validation project plans and protocols, execute protocols and write final reports independently with some peer review.
• Coordinate testing schedule with impacted area managers and quality control based on project needs.
• Create, review, and develop department standard operating procedures as required.
• Play a lead role in the successful completion of project milestones and crucial technical tasks.
• Participate in equipment failure investigations, corrective / preventive actions and equipment release. Provide final approval for equipment release.
• Provide assistance with calibration and metrology responsibilities as department needs require.
• Provide technical assistance and coaching to less experienced engineers when required.
• Additional quality activities as required.

Qualifications :

Preferred Qualifications :

Why Vericel?

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.