ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the 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 detailed oriented, organized, and have a strong desire to implement projects and drive improvement initiative to systems and program. Key responsibilities will 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 be working with seasoned Engineers and Facilities Technicians and supporting them to oversee vendor performed maintenance/calibrations on GMP Utility systems, process equipment and clean room infrastructure.
Here’s What You’ll Do:
- Ability to perform tasks in highly regulated industrial environment with adhere to safety and quality program policies.
- Hand on experience with troubleshooting equipment and utility issues with root cause analysis, work order management, corrective and preventive actions, and continuous improvement initiatives.
- Knowledge of HVAC systems, pressurization, airflow, temperature, and humidity performance. Knowledge of compendial water, steam, and gas systems.
- Support engineering lifecycle process for GMP HVAC systems, supporting base building utilities (Steam, Chill Water, Hot Water, Cooling Tower), water for injection, pure steam, liquid nitrogen, clean compressed gas utilities (CO2, O2, N2, and CA), vacuum, electrical systems (uninterruptible power supply, standby power, normal power), Biokill waste processing and pH neutralization systems to support Cell Therapy and Viral Vector clinical manufacturing.
- Promote operational excellence for asset management lifecycle, maintenance programs, and calibration programs for GMP facilities and utilities systems. Support asset management lifecycle in the CMMS.
- Provide customer service support to Facilities and Engineering team to align with department objectives. Participate in safety programs to mitigate and resolved safety risks in lab and manufacturing environments.
- Support quality management and engineering change management lifecycle for commissioning, validation, and standard operating procedure.
- Lead walk down of engineering drawings, piping, and instrumentation diagrams, for electrical, mechanical, plumbing, building management system and architecture. Perform commissioning test protocol for base building infrastructure and utility systems.
- Support facility and utility shutdown planning and utility expansion planning. Support small capital projects and safety improvements project scopes for facility and utility systems.
- Support development of reliability and predictive maintenance objectives.
- Participate in project teams through all phases of engineering projects including design, constructions, startup installation, commissioning, validation, standard operating procedure development, maintenance plan development, and continuous improvement.
- Familiar with automated control systems, programmable logic controller, human machine interfaces, and human factors.
- Lead technical writing for standard operating procedures, engineering turnover package and engineering specifications in accordance with Good Engineering Practices.
- Manage quality events for change control, CAPAs, and deviation for facility and utility infrastructure.
- Work collaboratively with Facilities, Metrology, Capital Projects, Validation, Automation, Quality Control and Quality Assurance teams.
Requirements:
- BS Degree in Mechanical, Chemical, Facilities, Industrial Engineering or equivalent
- 3+ years’ experience in GMP biotech or FDA regulated environment
- 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 for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside 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 speed the world deserves.
Our Vision:
We seek 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 qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
