Director, Facilities Engineering

Overview

Join the Director of Engineering & Facilities role at Cellares
. We seek an innovative, highly motivated leader who will contribute significantly to Cellares’ mission to accelerate access to life‑saving cell therapies.

• Develop and implement facilities policies and practices (SOPs)
• Drive planning activities, including direct space allocations, moves, and facilities construction, modification, and maintenance
• Manage and coordinate equipment calibrations, preventive maintenance, and monitoring of equipment and utilities in non‑GMP and GMP areas (including repair, modification, and installation of equipment)
• Establish a computerized equipment maintenance and calibration program using a modern eQMS platform
• Manage a building monitoring program, including sourcing, approving, and implementing an electronic building monitoring system
• Support an equipment monitoring system for GMP‑related equipment
• Manages and coordinates the contract cleaning services for the GMP facility and office space areas
• Responsible for emergency repairs of the facility and equipment
• Review and approve equipment and facilities‑related contracts and vendor qualifications
• Manage and lead capital engineering projects and coordinate the facility pest control program for the GMP and non‑GMP areas
• Oversee Environmental Health and Safety (EHS) activities as they relate to the GMP and non‑GMP environments, including sourcing contract personnel for chemical and biological waste disposal
• Capture, analyze, prioritize, delegate, and communicate immediate, short‑term, and long‑term maintenance projects; support and assist with expertise in electrical, plumbing, welding, HVAC, refrigeration systems, and other equipment
• Respond to emergencies as appropriate during off‑hours, holidays, and weekends
• Develop and maintain accurate records of maintenance activities
• Responsible for monitoring and ordering compressed gases
• Oversee and manage third‑party service providers; manage the direct relationship with landlords and/or property managers to ensure correct building maintenance and compliance with contractual agreements
• Author Request Proposal (RFP) documents for vendors to bid on qualification work and provide vendor comparisons, and award qualified vendors
• Develop and implement commissioning and qualification procedures
• Author, review, and approve documents for departmental standard operating procedures (SOPs) and programs
• Generate and execute qualification documents, URS, RA, SAT, FAT, IQ, OQ, PQ, and summary reports to support GxP requirements
• Develop, review, and approve room qualification protocols for static and dynamic classified environments
• Author, assess, and execute Change Controls and Impact Assessments for Engineering/Facilities qualification projects
• Provide qualification project updates to stakeholders and management personnel, such as phase gate reviews, meeting minutes, status updates, and identification and tracking of project risks
• Demonstrate effective project leadership and team collaboration by completing all assigned projects on time, on budget, and successfully achieving qualification expectations in compliance with our safety policies and company regulations
• Manage and maintain the commissioning and qualification expense and capital budget
• Participate and lead in the development of corporate‑wide systems, procedures, and tools that facilitate efficient processes throughout the organization
• Ensure and support the EHS team in complying with all regulations and guidelines for a cell therapy manufacturing facility
• Maintain all commissioning and qualification data within a secure, structured CMMS system
• Ensure all assets are documented, maintenance plans are developed, assets are scheduled, and work orders are completed
• Take ownership of, develop, and/or continually improve commissioning and qualification programs
• Participate in external and internal compliance/regulatory audits
• Make critical decisions on equipment/facility issues and emergencies, effectively communicate to management, and elevate issues as needed

• Bachelor's or Master's degree in Engineering or related field
• 10+ years of direct experience working in a…