Director of Engineering & Facilities

We are seeking an innovative and highly motivated Director, Engineering and Facilities, 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, Engineering and Facilities, 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.

Responsibilities

• 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
• Manage 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 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

About 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.

Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options.

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