Director, Facilities Engineering

• 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
• Responds to emergencies as appropriate during off-hours, holidays, and weekends
• Develops and maintains accurate records of maintenance activities
• Responsible for monitoring and ordering compressed gases
• Oversees and manages 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, 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
• Generation and execution of 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 escalate issues as needed

• Bachelor's or Master's degree in Engineering or related field
• 10+ years of direct experience working in a GMP-regulated facility in the pharmaceutical or life sciences arenas is a must
• A minimum of 3 years of experience working in a cell therapy or pharmaceutical manufacturing environment, with at least 1 of those years in a director of operations role
• Hands-on experience with autologous and/or allogeneic cell therapy manufacturing processes
• Direct experience managing facility office space
• Detailed knowledge of manufacturing technology, industry trends, and requirements associated with the introduction of new equipment/methods into a manufacturing setting
• Demonstrated success managing CAPEX projects, facility buildouts, and utility systems
• Comprehensive understanding and extensive practical experience with GMP quality systems and procedures
• Excellent technical writing skills with an understanding of good documentation practices
• Ability to adapt and evolve quickly in an ever-changing and dynamic environment
• Self-motivated and able to collaborate well cross-functionally with other department managers and personnel
• Should be passionate about advancing the field of cell therapies
• Self-awareness, integrity, authenticity, and a growth mindset
• Must be able to travel up to 20% of the time

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.