Director, Facilities Engineering jobs in United States
cer-icon
Apply on Employer Site
company-logo

Cellares · 2 weeks ago

Director, Facilities Engineering

Cellares is an Integrated Development and Manufacturing Organization focused on accelerating access to life-saving cell therapies. The Director, Facilities Engineering will manage operations and maintenance of facilities, ensuring compliance with GMP and EHS standards while leading capital expansion projects and facility improvements.

BiotechnologyLife ScienceManufacturingMedicalTherapeutics
check
Growth Opportunities
check
H1B Sponsor Likelynote

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

Qualification

GMP operationsFacilities managementCAPEX project managementCell therapy manufacturingEHS complianceUtility systems managementTechnical writingCollaborationSelf-motivationIntegrityGrowth mindset

Required

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

Benefits

Highly subsidized Medical, Dental, and Vision Plans
401(k) Matching
Free EV Charging
Onsite lunches
Stock options

Company

Cellares

twittertwitter
company-logo
Cellares is a life sciences technology company that develops the Cell Shuttle to automate cell therapy manufacturing.

H1B Sponsorship

Cellares has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (2)
2023 (2)
2022 (1)
2020 (1)

Funding

Current Stage
Growth Stage
Total Funding
$355M
Key Investors
Koch Disruptive TechnologiesEclipse Ventures
2023-08-23Series C· $255M
2021-05-05Series B· $82M
2020-10-29Series A· $18M

Leadership Team

leader-logo
Fabian Gerlinghaus
Co-Founder & CEO
linkedin
leader-logo
Omar Kurdi
Co-Founder and President
linkedin
Company data provided by crunchbase