Facilities Engineer

ElevateBio; Waltham (MA); On-site; USD 70,000 - 110,000; Full time

Job summary

Join a forward-thinking company at the forefront of cell and gene therapy innovation. As a Facilities Engineer, you will play a crucial role in implementing and improving systems that support cutting-edge biotech processes. Your expertise will contribute to the maintenance and optimization of complex utility systems, ensuring compliance with GMP standards. Collaborate with a talented team to drive operational excellence, enhance safety protocols, and support transformative projects that redefine the future of medicine. This is your opportunity to make a significant impact in a dynamic and rapidly evolving industry.

Benefits

Health Insurance

401(k) Plan

Paid Time Off

Flexible Work Hours

Professional Development Opportunities

Qualifications

• 3+ years in GMP biotech or FDA-regulated environments.
• Detail-oriented with strong project implementation skills.
• Experience with utility systems and engineering projects.

Responsibilities

• Support small and large capital projects in a regulated environment.
• Troubleshoot equipment and utility issues with root cause analysis.
• Lead technical writing for SOPs and engineering documentation.

Skills

HVAC Systems Knowledge

Root Cause Analysis

Technical Writing

Project Management

Interpersonal Skills

Education

BS Degree in Mechanical Engineering

BS Degree in Chemical Engineering

BS Degree in Industrial Engineering

Tools

Automated Control Systems

PLC

HMI

CMMS

Job description

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

ElevateBio is seeking a Facilities Engineer. The successful candidate will be detail-oriented, organized, and have a strong desire to implement projects and drive improvement initiatives for systems and programs. Key responsibilities include walking down complex utility systems and drawings, supporting small and large capital projects, technology transfer projects, and participating in project teams through all phases of engineering projects. This candidate will work with seasoned Engineers and Facilities Technicians, supporting them to oversee vendor-performed maintenance and calibrations on GMP Utility systems, process equipment, and clean room infrastructure.

Here’s What You’ll Do:

• Perform tasks in a highly regulated industrial environment, adhering to safety and quality program policies.
• Troubleshoot equipment and utility issues with root cause analysis, work order management, corrective and preventive actions, and continuous improvement initiatives.
• Have knowledge of HVAC systems, pressurization, airflow, temperature, humidity performance, and compendial water, steam, and gas systems.
• Support the engineering lifecycle process for GMP HVAC systems and supporting base building utilities, including Steam, Chill Water, Hot Water, Cooling Tower, water for injection, pure steam, liquid nitrogen, clean compressed gases (CO2, O2, N2, CA), vacuum, electrical systems, waste processing, and pH neutralization systems to support Cell Therapy and Viral Vector manufacturing.
• Promote operational excellence for asset management lifecycle, maintenance programs, and calibration programs for GMP facilities and utilities, supporting asset management lifecycle in the CMMS.
• Provide customer service support to Facilities and Engineering teams to align with department objectives. Participate in safety programs to mitigate and resolve safety risks in lab and manufacturing environments.
• Support quality management and engineering change lifecycle processes, including commissioning, validation, and SOP development.
• Lead walk-downs of engineering drawings, piping, and instrumentation diagrams for electrical, mechanical, plumbing, BMS, and architecture. Perform commissioning test protocols for infrastructure and utility systems.
• Support facility and utility shutdown planning, utility expansion planning, small capital projects, and safety improvement projects.
• Assist in developing reliability and predictive maintenance objectives.
• Participate in all phases of engineering projects, from design and construction to startup, commissioning, validation, SOP development, maintenance planning, and continuous improvement.
• Be familiar with automated control systems, PLCs, HMI, and human factors.
• Lead technical writing for SOPs, engineering turnover packages, and specifications in accordance with Good Engineering Practices.
• Manage quality events, including change control, CAPAs, and deviations related to facility and utility infrastructure.
• Collaborate with Facilities, Metrology, Capital Projects, Validation, Automation, QC, and QA teams.

Requirements:

• BS Degree in Mechanical, Chemical, Facilities, Industrial Engineering, or equivalent.
• 3+ years of experience in GMP biotech or FDA-regulated environments.
• Organized, independent, and collaborative.
• Strong interpersonal, technical writing, and verbal communication skills.

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and in the future. The company commercializes enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across various therapeutic modalities. Our ecosystem combines multiple R&D platforms—including Life Edit, cell engineering, and viral/non-viral delivery—alongside BaseCamp, our end-to-end cGMP manufacturing and process development business, to accelerate therapeutics discovery and development.

We aim to be the leading engine behind the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission: To power the creation of life-transforming cell and gene therapies at a pace the world deserves.

Our Vision: To be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created, and how disease is treated.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and applicants, regardless of race, color, gender, age, religion, national origin, disability, veteran status, genetic information, sexual orientation, or any characteristic protected by law. We will provide reasonable accommodations for qualified individuals with disabilities, as required by law.