Metrology Lead chez Vericel Corporation

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: 

This role is primarily responsible for calibrating and coordinating the calibration of a diverse range of electrical and mechanical equipment while adhering to good manufacturing practices. The role may also perform and/or assist with the installation, maintenance, testing and repair and of the equipment.

Schedule: This position is in-office Monday-Friday.

Position Scope:

• Manage vendors and calibrates instruments such as, RO systems, clean steam generators, autoclaves, parts washer systems, lab equipment, and manufacturing equipment. 
• Develop and maintain the Blue Mountain Regulatory Asset Manager (BMRAM) system.
• Maintain all calibration records and instrument tagging. 
• Write/develop Standard Operating Procedures (SOPs), and/or protocols.
• Write initial deviations using the QMS system.
• Assist in change control documentation and deviation notifications.
• Serve as information resource for validation technicians, contractors and vendors.
• Perform scheduled, new and emergency calibrations activities with vendors on all critical process equipment and lab instrumentation ensuring compliance with SOPs and cGMPs.
• Troubleshoot instrument control loops like temperatures, pressure, flow controllers, etc.
• Follow all environmental, health, and safety requirements and protocols.
• Understand schematics, logic ladder diagrams, and P&IDs.
• Identify/coordinate inventory for spare parts used on critical instruments.
• Support operations during 1st shift and be available after hours as needed to support the business.
• Assist in equipment selection, specification and commissioning.
• Other duties as assigned.

Qualifications: 

• Bachelors degree in STEM or High School degree with equivalent years of experience.
• Minimum 6+ years related experience in the areas such as temperature, pressure, flow (liquid & gas), pH, conductivity, humidity, lab instrumentation controllers, depyrogenation oven, steam generators, steam boilers, air compressor, vacuum pumps, and lab instrumentation.
• Knowledge of pharmaceutical manufacturing process equipment and lab instrumentation.
• Basic knowledge on cleanroom classifications.
• Familiarity with FDA, cGMP, SOPs, ASNI/NCSL, EU and ISO standards.
• Good organizational skills.
• Experience utilizing quality manage systems like Trackwise and BMRAM preferred.
• Excellent verbal, writing and interpersonal communication skills.
• Ability to gown and gain entry to manufacturing areas wearing personal protection equipment - safety glasses, gloves, gowns, etc. 
•  Ability to be available after hours as needed to support the business.
• Ability to lift up to 25 lbs.

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.