Validation Engineer, I

Vericel Corporation • Cambridge, MA

2d • $64,000 - $87,000

About The Position

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).

The Validation Engineer role performs equipment, utility, cleaning, sterilization, software, and process validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for cell therapies products in a GMP biotech manufacturing facility.

Requirements

• Bachelor's Degree or equivalent work experience and 1 - 2 years validation experience
• 1+ years of experience with process, equipment, utility and/or software validation in a GMP regulated environment.
• 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.

Nice To Haves

• Proficient with GE Kaye Validator and/or ValProbe data acquisition systems.
• 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 and final reports and managing validation projects.
• Ability to read/interpret engineering drawings and design documents.
• Knowledge of risk management tools and techniques.

Responsibilities

• 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.
• Analyze validation results and compile data into reports for initial qualifications and re-qualifications.
• Coordinate testing schedule with impacted area managers and quality control based on project needs.
• Provide input to technical composition of standard operating procedures.
• Generate custom validation protocols, execute protocols and write final reports.
• Review and provided edits as needed to department standard operating procedures.
• Investigate and troubleshoot validation problems, with proper oversight.
• Participate in equipment failure investigations, corrective/preventive actions and equipment release.
• For assigned projects, manage successful completion of project milestones and crucial technical tasks.
• Provide assistance with Calibration and Metrology liaison responsibilities as department needs require.
• Participate in peer review and approval of validation documentation.
• Other duties as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level