Facilities Engineer

ElevateBio; Waltham (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in the biotech sector is seeking a Facilities Engineer to support complex utility systems and capital projects. The role involves troubleshooting, managing quality events, and collaborating with various teams to ensure operational excellence in a GMP environment.

Qualifications

• 3+ years’ experience in GMP biotech or FDA regulated environment.
• Strong interpersonal, technical writing, and verbal communication skills.

Responsibilities

• Support engineering lifecycle process for GMP HVAC systems.
• Lead technical writing for standard operating procedures.
• Participate in project teams through all phases of engineering projects.

Skills

Troubleshooting

Root Cause Analysis

Customer Service

Technical Writing

Education

BS Degree in Mechanical Engineering

BS Degree in Chemical Engineering

BS Degree in Facilities Engineering

BS Degree in Industrial Engineering

Tools

Automated Control Systems

Programmable Logic Controller

Human Machine Interfaces

Job description

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