Director, Facilities Engineering

We are seeking an innovative and highly motivated Director, Facilities Engineering, who will contribute significantly to the growth of Cellares and our mission to accelerate access to life-saving cell therapies.

The primary focus of this position, as Director, Facilities Engineering, is responsible for management, operations, and maintenance of all facilities and supporting systems in compliance with GMP, quality, and EHS standards. This role oversees office space, cGMP cleanroom suites, QC laboratories, warehouse, utility systems (gases, HVAC, lab equipment, etc.), and equipment supporting cell therapy operations. In addition, the Director leads the maintenance and calibration program, cleaning program, and capital expansion projects (CAPEX), including buildouts.

The ideal candidate is an experienced facilities leader with a strong background in cGMP operations within the biotech or pharmaceutical industry. This individual will provide vision and leadership to ensure reliable facility operations, compliance with state and federal regulations, and continuous improvement of processes to support business growth.

This is a multidisciplinary role, and this individual will interface across many parts of the company (with scientists, researchers, and engineers) to develop the best solutions possible. The successful candidate will be driven, motivated, and self-sufficient.

Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.

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 equipmentReview and approve equipment and facilities-related contracts and vendor qualifications
• Manage and lead capital engineering projectsManage 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 projectsSupport 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 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
• 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

This is Cellares

Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.

Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.