Director, Facilities & Engineering

Vericel Corporation•Cambridge, MA

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Chemical Engineering, Facilities 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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.