Vericel® Corporation · 14 hours ago
Validation Engineer, I
Cambridge, MA
Full-time
Onsite
Entry Level
$64K/yr - $87K/yr
1+ years expVericel Corporation is a pioneer in advanced cell therapies for sports medicine and severe burn care. The Validation Engineer role is responsible for performing validation activities to ensure compliance with company procedures and industry standards in a GMP biotech manufacturing facility, including equipment and process validation.
BiotechnologyLife ScienceTherapeutics
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
Qualification
Required
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
Preferred
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
Benefits
Bonus
Incentive pay
Equity
Benefits
Company
Vericel® Corporation
Vericel is a leading provider of advanced therapies for the sports medicine and severe burn care markets.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$157.3MKey Investors
Eastern Capital
2018-06-07Post Ipo Equity· $74.8M
2016-12-16Post Ipo Equity· $20M
2012-03-09Post Ipo Equity· $40M
Leadership Team
J
Jonathan Siegal
Vice President and Corporate Controller
Karen Mahoney
Chief Human Resources Officer
Recent News
2026-01-15
Benzinga.com
2026-01-15
2025-11-07
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