Director, Facilities Engineering

Responsabilities

• 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

Requirements

• 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