Sr. Validation Engineer

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:

Engineering/science bachelor's degree with a minimum of 10 years of validation experience or Master's degree with a minimum of 8 years' experience.

Experience in process, equipment, utility, and/or software validation in a GMP regulated environment.

Familiarity with temperature chambers, sterilization, cleaning, software and depyrogenation qualifications.

Proficient with GE Kaye Validator and/or Ellab data acquisition systems.

Ability to work and collaborate with team and cross functional groups.

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.

Able to lift up to 40 lbs. Preferred Qualifications:

Excellent technical writing and verbal communication skills.

Strong math and statistical skills.

Experience with Microsoft Office including Excel, PowerPoint, Word, Project and Visio.

Proficient working in BMRAM and Kneat.

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.

Prior experience supervising personnel. Why Vericel?

Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.

Career Growth: Be a part of a growing organization with opportunities to expand your impact.

Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives.

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.

Permanent