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Director, Facilities & Engineering

Vericel Corporation

Job Description

Job Description

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 Director, Facilities & Engineering provides site leadership for facilities, utilities, manufacturing equipment, process instrumentation, and engineering services supporting a regulated biotechnology manufacturing environment. The role is accountable for safe, compliant, reliable, and cost-effective operation of site assets across their lifecycle, including design, startup, commissioning, qualification support, maintenance, troubleshooting, optimization, upgrades, and retirement. The Director leads the Facilities & Engineering organization, sets maintenance and reliability strategy, manages departmental resources and budgets, and partners cross-functionally to support production, quality, compliance, and business objectives. 

Schedule:  This position is onsite Monday - Friday, primarily at our Cambridge, MA office. Some time will also be required in our Burlington, MA office as well.

Key Responsibilities:

Leadership & Organization 

  • Lead, develop, and retain a high-performing Facilities & Engineering team; establish clear accountabilities, goals, succession plans, and development priorities. 
  • Provide coaching, performance feedback, recognition, and corrective action as appropriate, and ensure managers effectively carry people-leadership responsibilities through the organization. 
  • Establish departmental priorities, resource plans, training plans, and performance metrics aligned with site and company objectives. 
  • Promote a culture of safety, quality, compliance, collaboration, ownership, and continuous improvement.

Facilities, Engineering & Reliability

  • Own the site strategy for facilities, critical utilities, manufacturing equipment, process instruments, building infrastructure, and associated lifecycle support. 
  • Ensure robust preventive and corrective maintenance programs, asset reliability practices, spare-parts strategy, and effective use of the computerized maintenance management system (CMMS). 
  • Partner with Manufacturing and other stakeholders to plan maintenance windows, shutdowns, emergency work, and resource allocation while minimizing operational disruption. 
  • Oversee troubleshooting, root-cause resolution, equipment and facility upgrades, and continuous-improvement initiatives that improve reliability, capacity, compliance, and total cost of ownership. 
  • Ensure appropriate prioritization and execution of scheduled work orders and emergency work requests in a 24/7 biotechnology manufacturing environment. 

Capital Projects & Technical Execution 

  • Provide leadership and governance for Facilities & Engineering projects from concept through design, construction, startup, commissioning, qualification support, turnover, and closeout. 
  • Ensure projects are appropriately scoped, resourced, risk-managed, and delivered to approved safety, quality, schedule, and budget expectations. 
  • Manage engineering consultants, contractors, service providers, and vendors; establish clear performance expectations and ensure effective coordination during shutdowns and project execution. 
  • Design and implement facility and equipment improvements that support corporate objectives, production targets, future capacity, and lifecycle needs. 

Compliance & Cross-Functional Partnership 

  • Ensure Facilities & Engineering activities are performed in accordance with cGMP, applicable FDA and other regulatory requirements, company quality systems, and approved procedures.
  • Represent Facilities & Engineering during regulatory inspections, customer audits, internal audits, and compliance reviews; own or support timely resolution of observations and commitments. 
  • Partner closely with Manufacturing, Quality Assurance, Validation, Metrology, Scientific/Technical groups, and other support functions to coordinate work and resolve site issues. 
  • Ensure accurate, complete, and timely maintenance and engineering documentation, including cGMP record review and controlled permits/forms as applicable. 
  • Identify, address, and appropriately escalate site compliance, reliability, capacity, and infrastructure risks. 

Financial & Business Management 

  • Develop and manage the departmental operating budget and headcount plan; provide input to broader site and organizational planning. 
  • Develop business cases and recommendations for maintenance, reliability, infrastructure, and capital investments based on risk, compliance, capacity, lifecycle, and business impact. 
  • Use department and site metrics to monitor performance, communicate progress, identify trends, and drive corrective actions. 

Basic Qualifications 

  • Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, or a related technical field. 
  • A minimum of 12 years of progressively responsible facilities, engineering, maintenance, or related experience in biotechnology, pharmaceutical, or other highly regulated manufacturing, including significant people-leadership responsibility. 
  • Demonstrated knowledge of cGMP, FDA expectations, and engineering/maintenance practices in a regulated manufacturing environment. 
  • Comprehensive knowledge of building infrastructure, critical utility systems, manufacturing equipment, maintenance and reliability programs, and facility lifecycle management. 
  • Experience leading complex engineering or facilities projects, shutdowns, contractors, and cross-functional technical teams. 
  • Experience with CMMS platforms and strong working knowledge of maintenance records, work-order prioritization, preventive maintenance, and spare-parts management. 
  • Experience participating in regulatory inspections or quality audits and supporting compliant documentation and issue resolution. 
  • Strong leadership, communication, problem-solving, prioritization, vendor-management, and stakeholder-management skills. 
  • Proficiency with Microsoft Office and related business systems. 

Preferred Qualifications 

  • Advanced degree in engineering, business, or a related discipline. 
  • Experience in cell therapy, biologics, aseptic manufacturing, or other complex cGMP manufacturing environments. 
  • Construction management, capital planning, commissioning/startup, or reliability-centered maintenance experience. 
  • Professional certification or licensure relevant to engineering, facilities, maintenance, project management, or reliability.

Working Conditions and Physical Demands

  • Off-shift accessibility and participation in site response may be required based on business and operational needs. 

  • Role requires regular presence in manufacturing, mechanical, utility, construction, and cleanroom areas and may require appropriate gowning and personal protective equipment. 

  • Job may require physical activity, including walking, climbing stairs/ladders, and occasional lifting consistent with site requirements.

Vacancy posted 20 days ago
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