Vericel® Corporation

Validation Engineer

Vericel® Corporation

full-time

Posted on:

Location Type: Office

Location: Cambridge • Massachusetts • United States

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Salary

💰 $64,000 - $87,000 per year

Job Level

Junior

About the role

  • 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.

Requirements

  • Bachelor's Degree or equivalent work experience
  • 1 - 2 years validation experience
  • 1+ years of experience with process, equipment, utility and/or software validation in a GMP regulated environment.
  • 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
  • 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.
  • Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
validationinstallation qualificationsoperational qualificationsperformance qualificationstechnical writingstatistical skillstroubleshootingwriting validation protocolsmanaging validation projectsrisk management
Soft Skills
verbal communicationteam playerpeople oriented
Certifications
Bachelor's Degree